MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 2.7 MM LOCKING SCREW 18 MM LENGTH; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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.
Event or Problem Description
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.

• Brand Name: 2.7 MM LOCKING SCREW 18 MM LENGTH
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9888002
• Report Number: 0001822565-2020-01118
• Device Sequence Number: 19628970
• Product Code: HRS
• UDI-Device Identifier: 00889024100688
• UDI-Public: (01)00889024100688
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063303
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47482801802
• Device Lot Number: 63470831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 03/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention