MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-12-17 for DURAHOOK 1/4 HOOK 10 PKG/BX 6 HKS/PKG 382800 manufactured by Teleflex Medical.
[130542630]
Qn# (b)(4). The facility has communicated that the device is not available for evaluation. P/n 382800 is not being manufactured currently, however, another part number from the same family was use for the verification of failure mode reported in the current manufacturing process and was conducted as follows: 125 staplers were taken from the current production from p/n 382805 durahook 1/4 hook 10 pkg/bx 6 hks/pkg lot# 73l1800875 the staplers were visually inspected and issue reported "hook broken" was not observed in the current manufacturing process. A device history review could not be conducted since the lot number was not provided. Corrective actions cannot be established, the customer complaint cannot be confirmed, and the root cause cannot be determined since it is necessary to receive the physical sample to perform a proper investigation and to confirm the alleged defect. If the alleged defective samples become available at a later date, this complaint will be updated accordingly. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[130542631]
It was reported that the hook was placed in the skull skin flap during procedure. Hooks were removed after the case. It was later noticed that one of the hooks was broken. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2018-01021 |
| MDR Report Key | 8170763 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-12-17 |
| Date of Report | 2018-12-05 |
| Date of Event | 2018-11-30 |
| Date Mfgr Received | 2018-12-05 |
| Date Added to Maude | 2018-12-17 |
| 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 | EFFIE JEFFERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURAHOOK 1/4 HOOK 10 PKG/BX 6 HKS/PKG |
| Generic Name | INSTRUMENT, SURGICAL, NON-POWE |
| Product Code | HAO |
| Date Received | 2018-12-17 |
| Catalog Number | 382800 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-17 |