MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VERSA-DIAL SHOULDER SYSTEM HUMERAL HEAD IMPACTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	407297
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial procedure, the impactor tip fractured during impaction.The correct surgical technique was used.No complications, injuries, or surgical interventions were required, and no foreign bodies were retained due to this malfunction.The case was completed with a backup device without any adverse outcomes to the patient.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).The product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.An additional product was added to this event as the returned product, part number 407297, did not match the initially reported product, part number 110029132.Multiple mdr reports were filed for this event.Please see the associated reports referenced with applicable concomitant products below in the d10 narrative.D10: concomitant medical products, part (lot): 110029132 (unknown).The reported event is unable to be confirmed as the pad was not returned on the product 407297, and 110029132 was not returned.Visual examination of the returned product identified the strike plate and body showed signs of repeated use.However, as the pad product alleged to have fractured was not returned, further analysis could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided.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
No further event information is available at the time of this report.

• Brand Name: VERSA-DIAL SHOULDER SYSTEM HUMERAL HEAD IMPACTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 19402157
• Report Number: 0001825034-2024-01364
• Device Sequence Number: 20923951
• Product Code: HWA
• UDI-Device Identifier: 00880304456679
• UDI-Public: (01)00880304456679(11)210720(10)264230
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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 Catalogue Number: 407297
• Device Lot Number: 264230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 05/27/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: H11
• Patient Sex: Female