MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 25MM COMP RVS GLEN TRAY IMPTR; INSTRUMENT, EXTREMITIES

Catalog Number	405809
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that during a procedure the base of the impactor broke off.No consequences or impact to the patient.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d10; g4; g7; h1; h2; h3; h6.Visual examination of the returned product identified the strike plate has fractured from the shaft.Device was submitted for further analysis.Analysis determined the features of this fracture surface and mode align with those reported in summary of failure analysis of shoulder impactor threaded strike-plates.The common failure mode for the shoulder impactors presented in this summary was a fast-brittle type tensile/bending overload failure of the strike plate¿s threaded section.The reported products were reviewed for compatibility with no issues noted.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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.

• Brand Name: 25MM COMP RVS GLEN TRAY IMPTR
• Common Device Name: INSTRUMENT, EXTREMITIES
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9812619
• Report Number: 0001825034-2020-01029
• Device Sequence Number: 18996071
• Product Code: KWS
• UDI-Device Identifier: 00880304532298
• UDI-Public: (01)00880304532298
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K120121
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 405809
• Device Lot Number: 2923013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 07/28/2020
• 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: NI
• Patient Sequence Number: 1