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 2019-05-15 for CABLE CUTTER 1.8 MM MAXIMUM CABLE DIAMETER 00392501100 manufactured by Zimmer Biomet, Inc..
[145133315]
(b)(4). Report source: (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Product not returned.
Patient Sequence No: 1, Text Type: N, H10
[145133316]
It was reported by the sales representative that the customer received a new product but the cable cutter does not cut the cable properly. Cutting surfaces are not sharp enough. The cutter was tested immediately at the reception after opening from the package. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2019-02040 |
| MDR Report Key | 8612578 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2019-05-15 |
| Date of Report | 2019-11-27 |
| Date of Event | 2019-04-25 |
| Date Mfgr Received | 2019-11-21 |
| Device Manufacturer Date | 2019-03-21 |
| Date Added to Maude | 2019-05-15 |
| 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 | 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CABLE CUTTER 1.8 MM MAXIMUM CABLE DIAMETER |
| Generic Name | TRAUMA- INSTRUMENT |
| Product Code | HXZ |
| Date Received | 2019-05-15 |
| Returned To Mfg | 2019-09-06 |
| Catalog Number | 00392501100 |
| Lot Number | 64218646 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-05-15 |