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

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the g& inserter stuck out from the thop of the g7 cup.An alternate inserter was used with no further issue.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).Foreign source: japan.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: b4 d9 d10 g3 g6 h2 h3 h6 h10 one g7 str modular shell inserter item# 110003451 lot# 338440 was returned and evaluated.Upon visual inspection there was scuffing visible on the shaft along with wear marks.The strike plate has impact marks.No product was returned or pictures provided; visual and dimensional evaluations could not be performed for the threaded shaft.A review of the device history records identified no deviations or anomalies during manufacturing.Part and lot identification are necessary for review of device history records, but neither were provided for the threaded shaft.The device is used for treatment.Complaint history review cannot be performed without product identification for the threaded shaft.Complaint history review is not required for a limited investigation.Medical records were not provided.A definitive root cause cannot be determined for the threaded shaft.The investigation could not verify or identify any evidence of product contribution to the reported problem with the inserter.No corrective actions, preventive actions, or field actions resulted after the investigation of this event.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
There is no update to the original complaint description provided.

• 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: 15626725
• Report Number: 0001825034-2022-02344
• Device Sequence Number: 20419408
• Product Code: PBI
• UDI-Device Identifier: 00880304546615
• UDI-Public: (01)00880304546615(11)170802(10)338440
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 12/08/2022

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: 338440
• 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: 09/30/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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# 110010243 G7 SHELL LOT# 65513077; UNKNOWN THREADED SHAFT
• Patient Sex: Unknown