MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL CUT GUIDE LEFT MEDIAL 5 DEGREES CAPTURED DO NOT IMPLANT; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical product: 00590102000 - headless trocar drill pin 3.2 mm diameter 75 mm length - 64263779.Report source: (b)(6).Visual examination of the returned product for part 42539905185 exhibits signs of repeated use (nicked, gouged, burrs).The drill pin remained lodged and a dimensional analysis could not be performed.Visual examination of the returned product for part 00590102000 exhibits signs of repeated use (nicked, gouged, bent) and hex feature and tip is damaged.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.The dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found 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 an initial knee surgery, the pin would not release from the guide.The surgery was finished with the correction cut block.No known adverse event was reported.Attempts have been made and no additional information has been provided.

• Brand Name: TIBIAL CUT GUIDE LEFT MEDIAL 5 DEGREES CAPTURED DO NOT IMPLANT
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9716533
• Report Number: 0001825034-2020-00706
• Device Sequence Number: 366572
• Product Code: HTJ
• UDI-Device Identifier: 00880304809086
• UDI-Public: 00880304809086
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2020

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: 42539905185
• Device Lot Number: 63735849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 02/17/2020
• 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