MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-06-15 for PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE 399.36 manufactured by Synthes Tuttlingen.
[47417985]
Additional narrative: no known patient or surgical involvement. Exact date(s) of device breakages are unknown. Device is an instrument and is not implanted or explanted. Subject device has been received; no conclusions could be drawn as the device is entering the complaint system. Service history record review: no service history review can be performed as part 399. 36 with lot 5016318/ serial (b)(4) is a lot/batch controlled item. The release to warehouse date of this item is june 14, 2005. The service history review is unconfirmed. Device history record review: a review of the device history records has been requested and is currently pending completion. Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[47417986]
It was reported that seven (7) devices broken were found in a bin in the sterile processing department. The broken devices included: two (2) handles with quick coupling (small), a periosteal elevator, a screwdriver blade, a cruciform screwdriver shaft, a pair of reduction forceps, and a small hexagonal screwdriver with holding sleeve. An additional (non-reportable) issue was discovered with a screwdriver shaft that was stuck to a small handle with quick coupling. There was no known patient or surgical involvement. This report is 2 of 7 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[48633048]
Service and repair evaluation: the customer reported the handle is broken; the repair technician reported? Handle cracked/broken? As the reason for repair. The item is not repairable per the inspection sheet. The cause of the issue is unknown. The item will be forwarded for further evaluation. Device history record review: manufacturing date: 19th week of 2005. The dhr is no longer available due to the age of the instrument (over 11 years old). The exact date of manufacture is unknown. Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[50642913]
Product investigation summary: a visual inspection, functional test, and drawing review were performed as part of this investigation. The repair technician evaluated the parts and categorized each part as follows, deeming them non-repairable. Broken handle: handle with quick coupling (part: 311. 43 / lot: 7753306); periosteal elevator (part: 399. 36 / lot: a7oa16); and small hexagonal screwdriver (part: 314. 02 / lot: unknown); missing screwdriver blade: screwdriver blade w/ holding sleeve (part: 314. 67 / lot: 5393443); worn: cruciform screwdriver blade w/ holding sleeve (part: 314. 67. 97 / lot: 4132171); bent (loose): reduction forceps (part: 399. 99 / lot: a7pa49); burred: handle with quick coupling (part: 311. 43. 99 / lot: 4015618). The complaint conditions for all parts, except 311. 43. 99, could be confirmed. Part 311. 43 was returned with a transverse fracture with the proximal portion completely broken off and missing. Parts 399. 36 and 314. 02 had fractures along the dowel pins. Part 314. 67 was missing the screwdriver blade. The flange grips of part 314. 67. 97 were slightly splayed out, and the grip of the 399. 99 forceps was loose. As the circumstances leading to the damages are unknown, a definitive root cause could not be determined. For parts 311. 43, 314. 67. 97, and 399. 99, the failure mode is consistent with general wear and the application of excessive force over the life of the devices (2-16 years). For parts 399. 36 and 314. 02, repeated sterilization cycles have been known to degrade the handle? S material. For parts 314. 67 and 314. 67. 97, it is likely that inattentiveness during use or sterilization resulted in the complaint condition. The 311. 43. 99 handle was received with slight aesthetic burrs around the coupling, but the damage does not impact the functionality of the device. The handle was not broken. Therefore, the complaint is unconfirmed for part 311. 43. 99 and a detailed investigation was not performed. The relevant product drawings for each device were reviewed during the investigation. The design, materials, and finishing processes were all found to be appropriate for the intended use of these devices. No new, unique, or different patient harms were identified as a result of this evaluation. The design is adequate for its intended use when used and maintained as recommended. During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition. Device used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680938-2016-10082 |
| MDR Report Key | 5725868 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-06-15 |
| Date of Report | 2016-05-31 |
| Date Mfgr Received | 2016-07-21 |
| Device Manufacturer Date | 2005-06-14 |
| Date Added to Maude | 2016-06-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TERRY CALLAHAN |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES TUTTLINGEN |
| Manufacturer Street | UNTER HASSLEN 5 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERIOSTEAL ELEVATOR 6MM CURVED BLADE-ROUND EDGE |
| Generic Name | ELEVATOR |
| Product Code | HTE |
| Date Received | 2016-06-15 |
| Returned To Mfg | 2016-06-06 |
| Catalog Number | 399.36 |
| Lot Number | 5016318 |
| ID Number | (01)10886982202734(10)5016318 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES TUTTLINGEN |
| Manufacturer Address | UNTER HASSLEN 5 TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-15 |