MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 POSITIONING GUIDE ROD; HIPS, INSTRUMENTS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that when the surgeon was impacting the g7 cup, the positioning guide fell from the curved impactor and the surgeon and nurse noticed that the tip of the guide rod was broken.A small piece fell on the patient (not inside) and was retrieved.Another very small piece is still missing and was unable to be located with a possibility of landing inside the patient.
Additional Manufacturer Narrative
(b)(4).G2: foreign: canada.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 and/or corrected information.Visual examination of the returned product identified the device had fractured at the tip.There are wear marks along the shaft and gouging to the fractured tip.The device was sent for additional analysis.Fracture analysis of the fracture surface exhibited river lines and hinge artifacts suggesting that the device possibly fractured due to bending overload mode of failure.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records were not provided.A definitive root cause cannot be determined.Complaint confirmed based on the evaluation of the returned device.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 additional event information to report at this time.

• Brand Name: G7 POSITIONING GUIDE ROD
• Common Device Name: HIPS, INSTRUMENTS
• 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: 18836461
• Report Number: 0001825034-2024-00616
• Device Sequence Number: 15307440
• Product Code: LXH
• UDI-Device Identifier: 00880304676992
• UDI-Public: (01)00880304676992(11)230203(10)ZB7448453
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110018822
• Device Lot Number: ZB7448453
• 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: 02/12/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown