MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HYBRID OFFSET SHELL INSERTER; INSTRUMENT, HIP

Catalog Number	00780402520
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Concomitant medical devices: part #00-8757-060-00 / continuum tm shell/ lot # 64217707.
Event or Problem Description
It was reported that the threaded tip of the offset continuum cup inserter broke off in the dome hole of a continuum cup while impacting.The surgeon was unable to remove the broken portion of the inserter.The surgeon removed the cup and opened a new one and proceeded with the case.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h6 visual examination of the returned product identified wear and tear from previous uses.Shell inserter shows damage in the form of nicks, gouges, and scratches to the handle body, strike plate, and hex bolt.Threaded tip was confirmed fractured upon return.Fractured piece was not returned and was not present in the returned shell.Device history record (dhr) was reviewed and no discrepancies were found.Leading thread damage-the design of the cup positioner adaptor cap does not allow the leading thread to be chamfered because it is needed for better engagement with smaller diameter cups.As a result, the unchamfered leading thread is and has an increased tendency to strip, deform or fracture.Evidence of side impaction implies that the surgeons are placing off-axis load on the impaction handle which is designed to be struck on the impaction surface not the side of the handle.When struck on the side of the handle it creates unintended loading conditions and increased stress on the threads.Root cause of the event 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 further event information available at the time of this report.

• Brand Name: HYBRID OFFSET SHELL INSERTER
• Common Device Name: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 12672345
• Report Number: 0001822565-2021-03071
• Device Sequence Number: 12651500
• Product Code: FZX
• UDI-Device Identifier: 00889024134096
• UDI-Public: (01)00889024134096(11)190218(10)64167190
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 12/03/2021

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 Catalogue Number: 00780402520
• Device Lot Number: 64167190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2021
• 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: 09/29/2021
• Supplement Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male