MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. ROD GRIPPER; CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	07.02100.001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference report 3012447612-2022-00185.
Event or Problem Description
It was reported that the pivot screw closest to the tip of two vitality rod grippers broke intra-operatively, making them unusable.The polaris grippers were used to complete the surgery without patient impacts.This is report two of two for this event.
Event or Problem Description
It was reported that the pivot screw closest to the tip of two vitality rod grippers broke intra-operatively, making them unusable.The polaris grippers were used to complete the surgery without patient impacts.This is report two of two for this event.
Additional Manufacturer Narrative
Device evaluation: the returned devices match the information in the complaint file and were examined.Visual inspection revealed that the middle screw was missing from both devices.Potential root cause.A definitive root cause cannot be determined with the information provided.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimvie¿s control.Device usage: this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

• Brand Name: ROD GRIPPER
• Common Device Name: CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 15179057
• Report Number: 3012447612-2022-00186
• Device Sequence Number: 20386557
• Product Code: GDJ
• UDI-Device Identifier: 00889024010338
• UDI-Public: (01)00889024010338(10)63028625
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/17/2023

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 Catalogue Number: 07.02100.001
• Device Lot Number: 63028625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• 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: 07/14/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Male