MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-09-13 for CABLE CUTTER 1.8 MM MAXIMUM CABLE DIAMETER N/A 00392501100 manufactured by Zimmer Biomet, Inc..
[120244085]
(b)(4). (b)(6). Reported event is confirmed by review of the returned device. Upon visual inspection, the device was noted to have multiple scratches, gouges and nicks on the cutting jaw and handle ,indicative of use. There is a heavy indentation in the center of each jaw cutting edge indicating wear. Hardness check performed on the jaws noted that product to be conforming. A functional check was performed and the instrument failed to cut a 0. 71? Cable. Wear on the cutting edge leads to the dullness of the cutting edges causing the failure. Manufacturing records were reviewed and no discrepancies were found. Investigation results concluded that the reported event was due to normal wear during the instrument? S field life. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
[120244086]
It was initially reported that during an unknown surgery, cable cutters were found to not cut properly. No patient harm or adverse event was reported. During evaluation by zimmer biomet personnel, the device was found to have worn cutting edges.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-04868 |
| MDR Report Key | 7875074 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-09-13 |
| Date of Report | 2018-09-13 |
| Date of Event | 2018-04-29 |
| Date Mfgr Received | 2018-08-14 |
| Device Manufacturer Date | 2012-05-01 |
| Date Added to Maude | 2018-09-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CABLE CUTTER 1.8 MM MAXIMUM CABLE DIAMETER |
| Generic Name | CUTTER, WIRE |
| Product Code | HXZ |
| Date Received | 2018-09-13 |
| Returned To Mfg | 2018-07-11 |
| Model Number | N/A |
| Catalog Number | 00392501100 |
| Lot Number | 62068414 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-13 |