MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-09-26 for SHARP HOOK 319.390 manufactured by Synthes Bettlach.
[55692248]
Device used for treatment, not diagnosis. Unknown if patient was involved, patient information not available for reporting. Event date: unknown. Other udi: (b)(4) lot unknown. Implant and explant dates: device is an instrument and is not implanted/explanted. Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received. Device is not distributed in the united states, but is similar to device marketed in the usa. Initial reporter facility phone number: (b)(6). Pma 510k# unknown. Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received. 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
[55692249]
Device report from synthes on an event in (b)(6) as follows: it was reported that the reported drill sleeve had already had the broken tip at the time of delivery to a third-party (external) distributor. This complaint involves 1 part. This report is 1 of 1 for com-(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[58492887]
Manufacturing location: (b)(4). Manufacturing date: october 09, 2014. Neither deviation nor any non-conformance reports were marked in the device history record. 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
[59591007]
Device was used for treatment, not diagnosis. A manufacturing investigation was performed for the subject device. The product was returned in a packaging different from the original packaging. The laser marking was readable. Traces of repeated use were visible. Due to the broken tip, the dimensions of the sharp hook, relevant for the function, and drawing cannot be measured. The hardness of the hook was measured and it meets the specification. The material certificates meet the specification. A device history record review was performed for the affected lot, of the end product and also for its component, no abnormalities or deviations were detected, which could lead to the complaint failure. Based on this the complaint is rated as confirmed but not valid from the point of view of the manufacturing site. No manufacturing related issue was identified. It is likely that the tip broke due to repeated use of the instrument. The exact root cause could not be found. 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 | 2520274-2016-14692 |
| MDR Report Key | 5978329 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-09-26 |
| Date of Report | 2016-09-08 |
| Date Mfgr Received | 2016-11-09 |
| Device Manufacturer Date | 2014-10-09 |
| Date Added to Maude | 2016-09-26 |
| 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 | MARK VORNHEDER |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | SYNTHES BETTLACH |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH CH2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | CH2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHARP HOOK |
| Generic Name | HOOK, SURGICAL, GEN & PLASTIC SURGERY |
| Product Code | GDG |
| Date Received | 2016-09-26 |
| Returned To Mfg | 2016-09-30 |
| Catalog Number | 319.390 |
| Lot Number | 9155294 |
| ID Number | (01)07611819020948(10)9155294 |
| 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 BETTLACH |
| Manufacturer Address | MURACHERSTRASSE 3 BETTLACH PA CH2544 SZ CH2544 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-26 |