MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-23 for JOSEPH DOUBLE HOOK 5MM 410152 manufactured by Integra York, Pa Inc..
[90850520]
Integra has completed their internal investigation on october 13, 2017. Results: dhr review; lot number / serial number not received to perform dhr. Complaints history; two year look back in trackwise found a total of 0 complaints for (b)(4), for failures related to broke during use. Conclusion: failure analysis and root cause cannot be performed based on the lack of information provided by the customer. The hook was not returned for further evaluation.
Patient Sequence No: 1, Text Type: N, H10
[90850521]
Customer initially reports the item was being used on a patient when it broke in two pieces, both parts retrieved, no delay or injury during case. (b)(6) 2017 or manager reports event took place during an open reduction with internal fixation of the right index finger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00112 |
| MDR Report Key | 6967915 |
| Date Received | 2017-10-23 |
| Date of Report | 2017-10-02 |
| Date of Event | 2017-09-26 |
| Date Mfgr Received | 2017-12-06 |
| Device Manufacturer Date | 2011-08-01 |
| Date Added to Maude | 2017-10-23 |
| 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 | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | JOSEPH DOUBLE HOOK 5MM |
| Generic Name | N/A |
| Product Code | GDG |
| Date Received | 2017-10-23 |
| Returned To Mfg | 2017-12-05 |
| Catalog Number | 410152 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-23 |