MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-27 for 2.7 MM LOCKING SCREW 18 MM LENGTH N/A 47482801802 manufactured by Zimmer Biomet, Inc..
[185258907]
(b)(4). Multiple mdr reports were filed for this event, please see associated report: 0001822565-2019-00343. Medical product: distal lateral tibial plate left 6 holes 94 mm length; item# (b)(4), lot# 63139620. Source: (b)(6). Visual inspection of the returned product noted discoloration on the plate and the screw head. The returned products were sent to sem for additional evaluation. The foreign elements (c, n, o, na, mg, p, cl, k, and ca) identified in the discoloration indications on the distal lateral fibular plate and locking screw sample noted could be from various potential contaminants including biological soft tissue and bone, dried biological fluids (i. E. Blood), bone cement (calcium phosphate-based), corrosion/metal oxide product or various decontamination solutions (i. E. Hospital detergents). Therefore, the source of these elements is inconclusive. Signs of pitting corrosion observed within the locking threads on the screw sample and no indications of pitting corrosion observed on the plate sample. The eds analysis of the discoloration free area on the distal lateral fibular plate and locking screw samples showed that the elements identified in the spectra were consistent with (b)(4). Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified. A definitive root cause cannot be determined. 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
[185258908]
It was reported that a plate was explanted due to the customer thinking that it was linked to an ongoing investigation of the plp product at the hospital. There is no additional information available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2020-01118 |
| MDR Report Key | 9888002 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2019-01-10 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2016-10-14 |
| Date Added to Maude | 2020-03-27 |
| 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 | 2.7 MM LOCKING SCREW 18 MM LENGTH |
| Generic Name | PLATE, FIXATION, BONE |
| Product Code | HRS |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2019-09-12 |
| Model Number | N/A |
| Catalog Number | 47482801802 |
| Lot Number | 63470831 |
| 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 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-27 |