MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-16 for SHARP HOOK 319.39 manufactured by Synthes Monument.
[38870463]
Device was used for treatment, not diagnosis. No patient involvement reported. Unknown when device malfunctioned. Subject device has been received and is currently in the evaluation process. Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system. (b)(6). Device history records was conducted. The report indicates that the manufacturing location: supplier (b)(4), packaged by: (b)(4), manufacturing date: n/a part #: 319. 39, lot#:3922059 ((b)(4)) (non-sterile) - sharp hook, released on 02/23/1999. No ncrs were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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
[38870464]
Device report from synthes on an event in (b)(6) as follows: it was reported that two screwdrivers had worn out tips. One sharp hook was discovered in sterile processing with the tip broken off. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[40750370]
Device is an instrument and is not implanted or explanted. Product investigation summary: the part(s) were received in accordance with the complaint description. The complaint condition for the sharp hook was likely caused by the result of excessive force. The instrument was received with the distal tip broken off and not included/returned. The received condition is consistent with the result of excessive force. Thus, although the root cause cannot be definitively determined, it is probable that the method of use and/or handling resulted in the complaint condition. No non-conformance reports were generated during production. Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition. 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 | 1719045-2016-10132 |
| MDR Report Key | 5437963 |
| Date Received | 2016-02-16 |
| Date of Report | 2016-01-25 |
| Date Mfgr Received | 2016-03-18 |
| Device Manufacturer Date | 1999-02-23 |
| Date Added to Maude | 2016-02-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 MONUMENT |
| Manufacturer Street | 1051 SYNTHES AVE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| 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 | 2016-02-16 |
| Returned To Mfg | 2016-02-05 |
| Catalog Number | 319.39 |
| Lot Number | A7IA06 |
| ID Number | (01)10886982190253(10)A7IA06 |
| 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 MONUMENT |
| Manufacturer Address | 1051 SYNTHES AVE MONUMENT CO 80132 US 80132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-16 |