MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 0 DEGREE DISTAL CUT BLOCK; ORHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source - (b)(6).Customer has indicated that the product will be returned to zimmer biomet for investigation.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 a pin got stuck in the cutting block and caused it to be jammed.A pin was placed, which by thickness got stuck and there was no way to remove it, even after cleaning the piece after surgery.Another guide was used to complete the surgery.There is no additional information available at this time.
Additional Manufacturer Narrative
This follow-up is being submitted to relay additional information.Updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, and h10.Visual examination of the returned product identified signs of repeated use (saw blade indications) and the fractured drill pin remains lodged in one of the holes.Dimensional analysis of the product determined that the product, where measured, was conforming to print specifications.Medical records were not provided.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.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: 0 DEGREE DISTAL CUT BLOCK
• Common Device Name: ORHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11018701
• Report Number: 0001822565-2020-04118
• Device Sequence Number: 4396537
• Product Code: LXH
• UDI-Device Identifier: 00889024232419
• UDI-Public: (01)00889024232419
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2021

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: 42509901000
• Device Lot Number: 64592804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 04/01/2021
• 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