MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA BONE REDUCTION FCPS 51/2 W/RAT; N/A

Catalog Number	225137
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bone reduction forceps 51/2 w/ratchet (225137) broke during an orthopedic procedure, the operating room (or) team took an item from a replacement kit in order to proceed with the procedure.Staff had to perform a scan to make sure no parts were left before they closed the area.It was reported that the exact increase in procedure time was unknown but estimated 30-60 minutes.No patient injury has been reported.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The bone reduction forceps 51/2 w/ratchet (225137) was returned for evaluation: the device history record (dhr) was reviewed, and no anomalies related to the reported failure were observed.Failure analysis: visual evaluation of the forceps noted the unit was returned in used condition.Wear was visible on the surface of the handles.Root cause analysis: the reported complaint was confirmed.Sales records indicate that this lot number was last sold in (b)(6) 2022.It was determined that the returned forceps had one of the tips broken off due to wear or rough handling.No manufacturing, workmanship or material deficiency has been identified.
Event or Problem Description
N/a.

• Brand Name: BONE REDUCTION FCPS 51/2 W/RAT
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 18727068
• Report Number: 3014334038-2024-00028
• Device Sequence Number: 20392087
• Product Code: GEN
• UDI-Device Identifier: 10381780381785
• UDI-Public: 10381780381785
• Combination Product (Y/N): N
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2024

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 Catalogue Number: 225137
• Device Lot Number: AD2206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown