MAUDE Adverse Event Report: ARTHREX, INC. BIOSYNC ANATOMIC COTTON WEDGE, 20X7.5 MM; BONE WEDGE

Model Number	BIOSYNC ANATOMIC COTTON WEDGE, 20X7.5 MM
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on 09/01/2022 by a sales representative via email that an 8948w-2075 biosync wedge broke in the patient requiring a revision surgery to remove.
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
The complaint is confirmed based on the customer provided photo, which displays the broken wedge.However, without return of the device for physical evaluation, the cause remains undetermined.No change in harm was identified.

• Brand Name: BIOSYNC ANATOMIC COTTON WEDGE, 20X7.5 MM
• Common Device Name: BONE WEDGE
• 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: 15445778
• Report Number: 1220246-2022-05499
• Device Sequence Number: 18069728
• Product Code: PLF
• UDI-Device Identifier: 00888867266803
• UDI-Public: 00888867266803
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K151256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BIOSYNC ANATOMIC COTTON WEDGE, 20X7.5 MM
• Device Catalogue Number: AR-8948W-2075
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2022
• Supplement Date Received by Manufacturer: 09/01/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 03/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown