MAUDE Adverse Event Report: ARTHREX, INC. OSTEOCON FLAP REPR SINGSHOT INST; ORTHOPEDIC MANUAL SURG INSTR

Model Number	OSTEOCON FLAP REPR SINGSHOT INST
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a chondral dart surgery an attempt was made to fix a flake fracture with three darts.All three darts broke off during insertion, although the procedure was exactly as described in the operation instruction.The broken pieces were retrieved from patient.There was no harm for patient, operator or third party.The flake fracture was fixed successfully with 1.5mm screws by another manufacturer.It was not necessary to do a second surgery.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Complaint is not confirmed.Upon visual evaluation, four devices were returned inside the pouches without being opened.No problem was found with them.The reported device was not returned, and a photo was not provided for the investigation.No problem found.

• Brand Name: OSTEOCON FLAP REPR SINGSHOT INST
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 16931254
• Report Number: 1220246-2023-06743
• Device Sequence Number: 17822514
• Product Code: LXH
• UDI-Device Identifier: 00888867031272
• UDI-Public: 00888867031272
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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: OSTEOCON FLAP REPR SINGSHOT INST
• Device Catalogue Number: AR-4009S
• Device Lot Number: 15048243
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown