MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-17 for CALIPER 324.06 manufactured by Synthes Tuttlingen.
[26486063]
Event date: unknown. Implant and explant dates: device is an instrument and is not implanted/explanted. Service history review: part no: 324. 06, serial/lot no: (b)(4): no service history review can be performed as this is a lot controlled item. The manufacture date of this item is 27 march 1997. The source of the manufacture date is the release to warehouse date. The service history evaluation is unconfirmed. The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system. Device was 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
[26486064]
It was reported the device has a missing set screw. This occurred during testing, no case or patient involvement. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[32205805]
Service & repair evaluation: the customer reported the set screw was missing. The repair technician reported missing parts as the reason for repair. The cause of the issue is unknown. The following parts were replaced: set screw. This item was repaired, passed synthes final inspection, and will be returned to the customer upon completion of the service and repair process. (b)(4). 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 | 9680938-2015-10091 |
| MDR Report Key | 5083949 |
| Date Received | 2015-09-17 |
| Date of Report | 2015-09-04 |
| Date Mfgr Received | 2015-10-27 |
| Device Manufacturer Date | 1997-03-27 |
| Date Added to Maude | 2015-09-17 |
| 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 | LINDA PLEWS |
| 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 | CALIPER |
| Generic Name | CALIPER FOR CLINICAL USE |
| Product Code | KTZ |
| Date Received | 2015-09-17 |
| Returned To Mfg | 2015-09-10 |
| Catalog Number | 324.06 |
| Lot Number | XA7GA08 |
| 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 | 2015-09-17 |