MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MILLER/GALANTE UNICOMPARTMENTAL KNEE TENSION GAUGE; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source - foreign: (b)(6).The complainant 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.Investigation incomplete.
Event or Problem Description
It is reported that during kit inspection at the zimmer biomet spain warehouse, the tension gauge was identified to be broken.There was no patient involvement.No adverse events were identified as a result of this malfunction.
Additional Manufacturer Narrative
The complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product showed signs of repeated use.Analysis of the fracture determined that the fracture occurred near the end of a transition to a reduced thickness and was consistent with bending overload failure mode.The device history records were reviewed and no discrepancies were identified.A definitive root cause could not be determined with the information provided.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: MILLER/GALANTE UNICOMPARTMENTAL KNEE TENSION GAUGE
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 10886201
• Report Number: 0001822565-2020-03905
• Device Sequence Number: 3216531
• Product Code: LXH
• UDI-Device Identifier: 00889024192690
• UDI-Public: (01)00889024192690(10)63782106
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

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: 00578907100
• Device Lot Number: 63782106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 11/23/2020
• Supplement Report FDA Received Date: 02/18/2021
• 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