MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 STR MODULAR SHELL INSERTER; INSTRUMENT, HIP

Model Number	N/A
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported after implantation and when loosening the socket, the ball hex driver broke off.The shell could no longer be detached after repeated attempts from the insert handle and had to be removed together with the pan.An alternate device was used to complete the procedure.No adverse consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).Report source: foreign: switzerland.Customer has indicated that 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.Multiple mdr reports were filed for this event, please see associated reports, 0001825034-2022-02114, 0001825034-2022-02116.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4, b5, g3, g6, h2, h3, h6, h10 visual examination of the provided pictures identified the shell remains assembled with the inserter.The tip of the hex driver is fractured.Device history record was reviewed and no discrepancies relevant to the reported event were found.Root cause was 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and/or corrected information.One g7 ball hex drvr for insr hndl item# 010002736 lot# zb7037336, one g7 str modular shell inserter item# 110003451 lot# 541700, and one g7 osseoti 3 hole shell 50mm d item# 110010243 lot#7240122 were returned and evaluated.Upon visual inspection there is scuffing on the driver handle along with wear lines.The tip of the device had fractured.The inserter showed indentation near the rubber handle and to the strike plate.The inserter is stuck inside of the shell and could not be removed.The shell had no visible damage.The threads of the shell and inserter could not be checked due to not being able to separate them.A review of the device history records identified no deviations or anomalies during manufacturing.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: d4; g3; h2; h4; h6 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: G7 STR MODULAR SHELL INSERTER
• Common Device Name: INSTRUMENT, HIP
• 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: 15408980
• Report Number: 0001825034-2022-02115
• Device Sequence Number: 12172486
• Product Code: PBI
• UDI-Device Identifier: 00887868462498
• UDI-Public: (01)00887868462498(11)210830(10)541700
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K121874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/21/2023

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: 110003451
• Device Lot Number: 541700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/30/2022
• Supplement Date Received by Manufacturer: 10/14/2022; 03/15/2023; 04/20/2023
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 10/18/2022; 03/30/2023; 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2021
• 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: Unknown
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CAT#: 010002736 HEX DRIVER LOT#: ZB7037336.; CAT#: 110010243 G7 SHELL LOT#: 7240122.
• Patient Sex: Unknown