MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HEADED SCREW 48 MM LENGTH; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	5791-41
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an initial knee procedure, a headed screw fractured.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
(b)(4).Foreign: (b)(6).Customer has indicated that product will not be returned to zimmer biomet for investigation, as the product has been discarded.The investigation is in process.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 information.The following sections were updated/corrected updated: g3; h2; h3; h6 reported event was unable to be confirmed due to limited information provided by the customer.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.A summary of the investigation has been sent to the customer.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 additional event information to report at this time.

• Brand Name: HEADED SCREW 48 MM LENGTH
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14197273
• Report Number: 0001822565-2022-01188
• Device Sequence Number: 11833358
• Product Code: LXH
• UDI-Device Identifier: 00889024192805
• UDI-Public: (01)00889024192805(17)270831(10)63744809
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2022

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: 5791-41
• Device Catalogue Number: 00579104100
• Device Lot Number: 63744809
• Was Device Available for Evaluation?: No
• 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: 04/03/2022
• Supplement Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2017
• 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
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 70 KG