MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLEXIBLE REAMER 8.0 MM DIAMETER; TRAUMA, INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source: foreign: event occurred in (b)(6).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 that reamer broke during surgery.Attempts have been made and additional information on the reported event is unavailable at this time.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4, b5, d4(lot number), d9, e1 (last name), g3, h2, h3, h4, h6 complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product identified that the reamer shaft fractured just inside of the reamer head.Analysis determined the flexible reamer shaft fractured due to bending overload.Fracture surface revealed artifacts such as river lines and bending hinge that suggested crack propagation towards the outer diameter of the reamer.There were no clear indications of crack initiation, however it is suspected to be near the inner diameter of the reamer.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause could not 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 additional information at the time of this report.

• Brand Name: FLEXIBLE REAMER 8.0 MM DIAMETER
• Common Device Name: TRAUMA, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11581784
• Report Number: 0001822565-2021-00639
• Device Sequence Number: 14647957
• Product Code: HWE
• UDI-Device Identifier: 00889024038776
• UDI-Public: (01)00889024038776(10)64562716
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 08/17/2021

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: 00222800800
• Device Lot Number: 64562716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 08/18/2021
• 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