MAUDE Adverse Event Report: ZIMMER BIOMET, INC. G7 STR INSRTR THREADED SHAFT; INSTRUMENT, HIP

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: cat# 110010263 lot# 6833798 g7 osseoti multihole 50mm d.Cat# 00-6250-065-40 lot# 64710815 bone screw 6.5x40 selftap.Cat# 110024462 lot# 172570 g7 dual mobility liner 40mm d.Cat# 00-6250-065-20 lot# j6864071 trilogy bone scr 6.5x20.Cat# 00-8775-028-03 lot# 2821666 biolox 12/14 ceramic fem head +3.5x28.Cat# 01.00561.219 lot# 3023671 wagn cone prosthesis 125 19.Cat# 110031010 lot# 64722289 vivacit-e dm bearing 28x40mm.Cat# 31-323230 lot# 394620 3.2mmx30mm rnglc+ acet drl bit.Cat# 31-323220 lot# 232390 3.2mmx20mm rnglc+ acet drl bit.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.
Event or Problem Description
It was reported during a total hip arthroplasty that the straight inserter threaded shaft would not thread onto the head.There was no delay and patient was not affected.The returned device shows the tip was fractured.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
A g7 str insrtr threaded shaft was returned and evaluated.Upon visual inspection the threaded tip of the device had fracture.There are visible dark lines on the shaft of the device from use.Additional testing showed the fracture surface features of the threaded inserter align with those reported in the summary of failure analysis of threaded inserter tip fractures.The common failure mode for the threaded inserter tips presented in this summary is bending overload of the threaded tip, some of which may have also had minimal threads engaged at the time of fracture.A review of the device history records identified deviations or anomalies during manufacturing, however, the deviations or anomalies would not have been attributed to the event.A definitive root cause cannot 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
It was reported during a total hip arthroplasty that the inserter thread wouldn¿t attach to the cup and the impactor to insert the cup liner.There was no delay and patient was not affected.The returned device shows the tip was fractured.No further event information available at the time of this report.

• Brand Name: G7 STR INSRTR THREADED SHAFT
• Common Device Name: INSTRUMENT, HIP
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11665990
• Report Number: 0001825034-2021-00956
• Device Sequence Number: 16925965
• Product Code: PBI
• UDI-Device Identifier: 00880304551602
• UDI-Public: (01)00880304551602(11)151006(10)432508
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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 Model Number: N/A
• Device Catalogue Number: 110003452
• Device Lot Number: 432508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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: SEE H10.
• Patient Age: 50 YR