MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TRAUMA FIXATION SYSTEMS LONG INSERTER CONNECTOR; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	14-441043
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: item# 14-441045; lot# unknown.Item# 14-441043; lot# unknown.G2: foreign - event occurred in australia.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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 that during a procedure, the tip of the device fractured while the surgeon was using it to insert a screw into the nail.No patient harm or consequences were reported as a result of the event.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the provided picture identified the tip of the device to be fractured.Medical records were not provided.Lot identification is necessary for review of device history records, lot identification was not provided.The previously addressed root cause for this device failure was determined to be the lack of mechanical specifications for the design input of the instrument.However, as the lot information for the reported device is unknown, a definitive root cause cannot be determined.The reported event is confirmed, based on examination of the provided picture.If any further information which would change or alter any conclusions or information, a supplemental report 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.If any further information which would change or alter any conclusions or information, a supplemental report 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Performed a visual inspection of the item returned.The inserter returned shows signs of use with some galling on the shaft of the inserter near the proximal end of the shaft and near the middle section of the shaft.The threaded tip at the end of the inserter has fractured off and was not returned.Review of the device history records identified no deviations or anomalies during manufacturing.The root cause of the previous investigation remains unchanged.The reported event is confirmed, based on evaluation of the returned product.If any further information which would change or alter any conclusions or information, a supplemental report 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: TRAUMA FIXATION SYSTEMS LONG INSERTER CONNECTOR
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18975826
• Report Number: 0001825034-2024-00802
• Device Sequence Number: 6571116
• Product Code: LXH
• UDI-Device Identifier: 00887868093715
• UDI-Public: (01)00887868093715(11)200819(10)578620
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/04/2025

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: 14-441043
• Device Lot Number: 578620
• 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: Not provided
• Supplement Date Received by Manufacturer: 07/22/2024; 08/30/2024; 02/03/2025
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 07/23/2024; 09/06/2024; 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2020
• 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: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H10.
• Patient Sex: Male