MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEMPLATE HOLDING FORCEPS; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).G3: foreign source: japan.Customer 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.
Event or Problem Description
It is reported that during a procedure the surgeon discovered that the tip of the forceps was broken.The forceps had been used as usual.It was unknown whether this breakage occurred before or during the surgery.Surgery was completed using other forceps.The tip was looked for on x-rays after discovery of fracture, but it was not found in the surgical site.No harm or injury to the patient was reported.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned forceps.The forceps show signs of multiple uses including heavy marking and scratching on the instrument surface.Further investigation shows that one of the two tips has fractured.The fractured portion of the tip was not returned.The complaint is confirmed.A determination cannot be made as to what caused the tip to fracture.Review of the device history records identified no deviations or anomalies during manufacturing.A supplier dhr review was not performed as product has approximate field age of 10 years, with an unknown number of uses.The device shows signs of repeated use.A definitive root cause cannot be determined.The reported event is confirmed, based on product return.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted to update additional information in sections b4, b5, d9, g3, g6, h2, h3, h4, h6, and h11.

• Brand Name: TRAUMAONE SYSTEMPLATE HOLDING FORCEPS
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18875509
• Report Number: 0001032347-2024-00091
• Device Sequence Number: 21099594
• Product Code: MDM
• UDI-Device Identifier: 00841036284602
• UDI-Public: (01)00841036284602(10)A14
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/28/2024

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: 46-0005
• Device Lot Number: A14
• 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: 02/13/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 06/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2014
• 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: Unknown
• 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 Sex: Unknown