MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL BROACH CEMENTED SIZE E-F; INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported by the head of medical device reprocessing unit that the teeth on the broach are visibly chipped/fractured.Damage was not noticed in the operating room.
Additional Manufacturer Narrative
(b)(4) this follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d4, d10, e1, e2.E3, g3, g4, g7, h1, h2, h3, h6, h10 d4: udi # (b)(4) the complaint is confirmed.Visual evaluation of the returned instrument shows repeated use and some of the teeths were fractured.Dimensions were measured and found to be within print specification.Review of the device history record(s) (zb and supplier) identified no deviations or anomalies during manufacturing related to the reported event.Reported event did not occur in an operating room or as part of a medical procedure; medical records are not available for review.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
No further event information available at the time of this report.

• Brand Name: TIBIAL BROACH CEMENTED SIZE E-F
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9943293
• Report Number: 0001822565-2020-01036
• Device Sequence Number: 2240060
• Product Code: JWH
• UDI-Device Identifier: 00889024247338
• UDI-Public: (01)00889024247338
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K122765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2020

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 Model Number: N/A
• Device Catalogue Number: 42539902205
• Device Lot Number: 64305168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 08/17/2020
• 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