MAUDE Adverse Event Report: ZIMMER BIOMET, INC. NEXGEN LCCK ARTICULAR SURFACE WITH LOCKING SCREW 14MM SIZE E,F; PROSTHESIS, KNEE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a knee arthroplasty revision while the surgeon was inserting the articular surface screw, the screw fractured.The distal end of the screw was embedded into the tibial stem and not salvageable.The surgeon decided to leave the articular surface in place without a screw and was satisfied with the fixation of the implant.No post-operative complications have been identified and the patient has since been discharged home.
Additional Manufacturer Narrative
(b)(4).G2 - report source - foreign - event occurred in united kingdom.The complainant has indicated that the fractured screw is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.H3 other text : investigation incomplete.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information visual examination of the returned device identified signs of use (nicks/gouges) and the device was confirmed to be fractured.The device history records were reviewed and no discrepancies were identified.The surgical technique for the device states, "do not over or under torque.Under tightening of the screw may allow it to loosen over time.Overtightening may cause the screw to fracture intraoperatively" and to "only apply 95 inch pounds of torque with the wrench to assure the screw is properly tightened." as the screw snapped during tightening and was not replaced with a new screw, the root cause is attributed to failure to follow instructions.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: NEXGEN LCCK ARTICULAR SURFACE WITH LOCKING SCREW 14MM SIZE E,F
• Common Device Name: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16886575
• Report Number: 0001822565-2023-01203
• Device Sequence Number: 20411303
• Product Code: JWH
• UDI-Device Identifier: 00889024635821
• UDI-Public: (01)00889024635821(17)280131(10)64557496
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K960279
• 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): 09/28/2023

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: 00599404014
• Device Lot Number: 64557496
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2020
• 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: Initial
• 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: Prefer Not To Disclose