MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-03 for BMP CABLE SLEEVE/GRIP CRIMPER N/A 498003 manufactured by Biomet Trauma.
[69267804]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show the lot released with no recorded anomaly or deviation. In the package insert, under care and handling, it states: "surgical instruments are subject to wear with normal usage. Instruments, which have experienced extensive use or excessive force, are susceptible to fracture. Surgical instruments should only be used for their intended purpose. " (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[69267805]
It was reported that the clamp fractured during the tightening of the device. Device had been in use for 3-4 months. Another instrument was used to finished the surgery non-optimally. No further information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
[71876804]
This follow-up report is being submitted to relay additional information. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2017-01356 |
| MDR Report Key | 6377799 |
| Date Received | 2017-03-03 |
| Date of Report | 2017-09-25 |
| Date of Event | 2017-02-04 |
| Date Mfgr Received | 2017-09-22 |
| Device Manufacturer Date | 2016-09-26 |
| Date Added to Maude | 2017-03-03 |
| 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 | BIOMET ORTHOPEDICS |
| 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 | BMP CABLE SLEEVE/GRIP CRIMPER |
| Product Code | HXQ |
| Date Received | 2017-03-03 |
| Model Number | N/A |
| Catalog Number | 498003 |
| Lot Number | 765850 |
| ID Number | SEE H10 NARRATIVE |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET TRAUMA |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-03 |