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 Known Impact Or Consequence To Patient (2692)
Date of Event	12/01/2020
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.Udi #: (b)(4).Concomitant medical devices: item # 00875706001/ shell with cluster holes / lot # 64630622.
Event or Problem Description
It was reported that during an initial hip procedure the surgeon had the cup on the inserter handle and was manipulating the cup past the hip capsule and the screw on the inserter broke off into the cup.A new inserter and new implant were used to finish the case.A 30-minute surgical delay was noted.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.Visual evaluation identified the following: the leading threads on the hex bolt were fractured, and the fractured portion remained in the acetabular shell.There was wear and tear consistent with use over a potential field age of approximately 7 years and 3 months.No other damages were noted.Record (dhr) was reviewed and no discrepancies were found.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
• MDR Report Key: 11056816
• Report Number: 0001822565-2020-04204
• Device Sequence Number: 3311448
• Product Code: FZX
• UDI-Device Identifier: 00889024134096
• UDI-Public: 00889024134096
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2021

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: 62482784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1