MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MIS QUAD-SPARING HEADED SCREW 48MM; INSTRUMENT, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant devices - mis quad-sparing headed screw 48mm catalog #: 00598304048 lot #: 64691666.Report source - foreign: (b)(6) the complainant 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 patient; please see all reports associated with this event: 0001822565-2021-00313.Investigation incomplete.
Event or Problem Description
It is reported that during knee arthroplasty while the surgeon was inserting a screw into the femur through the spacer block femoral resector, the head of the screw fractured inside the inserter.The surgeon attempted to remove the screw from the device with pliers, resulting in a twenty-five (25) minute delay and an anterior micro fracture to the patient's femur.Attempts have been made, however, no additional information is available at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned device shows signs of repeated use.48mm screw was fracture and hex feature was jammed in the screw inserter/ extractor.Device was submitted for further analysis.Analysis determine hex head of the 48mm head screw suspected to have fractured due to torsional overload.Crack initiation site cannot be seen due to excessive smear in the fracture surface.Device history record was reviewed and no discrepancies relevant to the reported event were found.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
No further event information available at the time of this report.

• Brand Name: MIS QUAD-SPARING HEADED SCREW 48MM
• Common Device Name: INSTRUMENT, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11278117
• Report Number: 0001822565-2021-00314
• Device Sequence Number: 16785327
• Product Code: LXH
• UDI-Device Identifier: 00889024218277
• UDI-Public: (01)00889024218277(17)300331(10)64727483
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: 00598304048
• Device Lot Number: 64727483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 06/09/2021
• 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
• Outcome Attributed to Adverse Event: Other