MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLEXIBLE REAMER 6.0 MM DIAMETER; TRAUMA, INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2020
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 after removing the reamer from the medullary canal, the tip of the reamed slipped off from the shaft.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.Updated: d9; g3; h2; h3; h6.Complaint sample was returned and evaluated against the reported event.Visual inspection of the returned product noted the tip of the drill has moved from its initial position.Dimensional analysis noted the product shaft od is conforming to specifications.Dhr was reviewed and no discrepancies were found.The root cause is unable to 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 event information to report at this time.

• Brand Name: FLEXIBLE REAMER 6.0 MM DIAMETER
• Common Device Name: TRAUMA, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11462721
• Report Number: 0001822565-2021-00471
• Device Sequence Number: 17051941
• Product Code: HWE
• UDI-Device Identifier: 00889024038738
• UDI-Public: (01)00889024038738(10)64264469
• 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): 08/10/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 00222800600
• Device Lot Number: 64264469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 08/02/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 08/11/2021
• 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