MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-10-12 for STD BRL LAG SCRW 12.5X90MM N/A 236090 manufactured by Zimmer Biomet, Inc..
[90210262]
Zimmer biomet complaint (b)(4). This report is being submitted late as it has been identified in remediation. Complaint sample was evaluated and the reported event was confirmed. The complaint was confirmed after review of packaging confirms opening of the inner sterile pouch. Dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no trends were identified. Investigation results concluded that the reported event was due to shipping damage. 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
[90210263]
It was reported that during a hip fracture procedure. The sales representative opened the package containing the lag screw and discovered that the inner sterile packaging was already opened. A biomet hiploc was used to complete the procedure with no delay or patient injury. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-08611 |
| MDR Report Key | 6946198 |
| Report Source | OTHER |
| Date Received | 2017-10-12 |
| Date of Report | 2017-10-12 |
| Date of Event | 2014-12-13 |
| Date Mfgr Received | 2015-01-22 |
| Date Added to Maude | 2017-10-12 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STD BRL LAG SCRW 12.5X90MM |
| Generic Name | PROSTHESIS, TRAUMA |
| Product Code | JDO |
| Date Received | 2017-10-12 |
| Returned To Mfg | 2015-02-05 |
| Model Number | N/A |
| Catalog Number | 236090 |
| Lot Number | 1725567 |
| ID Number | N/A |
| Device Expiration Date | 2019-06-30 |
| 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 | 2017-10-12 |