MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE GH; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2020
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.
Event or Problem Description
It was reported that the tasp is chipped and broke off when taking off the poly trial in sterile processing department.
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: updated: b4, b5, d4, g4, g7, h1, h2, h3, h6, h10.D4: (b)(4).Performed a visual inspection of the returned item # 42517600707 lot # 63967634 found it to exhibit signs of repeated use and the rails have fractured off all pieces were not returned reference attached photographs.The device history records for the item # 42517600707, lot # 63967634 were reviewed for deviations and/ or anomalies with the following anomalies/ deviations identified.Ncr12271132 for etch not conforming/found to be conforming.The receiving inspection report for item # 42517650707, lot # 80853705 were reviewed for deviations and/ or anomalies with no deviations/ anomalies identified.Dhr supplier review found that the product was conforming to all specifications and no process deviations.A complaint history search identified 1 complaint for item # 42517600707 lot # 63967634 combination as of 24th september 2020.Complaints are monitored through monthly complaint review (reference (b)(4) and (b)(4)) in order to identify potential adverse trends.Evaluation of the returned device identified the fracture was consistent with the tasp fractures witnessed previously.The common failure modes for the tasp devices include either bending overload or low cycle fatigue culminating in bending overload as evident by the presence of hackle marks, river lines and striations features on the fracture surface a definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.

• Brand Name: CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL LEFT SIZE GH
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10543730
• Report Number: 0001822565-2020-03266
• Device Sequence Number: 16925122
• Product Code: JWH
• UDI-Device Identifier: 00889024238992
• UDI-Public: (01)00889024238992
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K123459
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

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: 42517600707
• Device Lot Number: 63967634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 09/30/2020
• 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