MAUDE Adverse Event Report: ARTHREX, INC. BONE REDUCTION FORCEPS, CURVED, POINTED; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	BONE REDUCTION FORCEPS, CURVED, POINTED
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/02/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the point of the ar-8943-07 reduction forceps tip broke off during surgery and was imbedded in the patient at the operative site.
Additional Manufacturer Narrative
The complaint is confirmed.One unpackaged ar-8943-07, batch 6671711 pair of bone reduction forceps were received for investigation.Visual inspection identified that the left tip of the forceps was both bent and noticeably broken.The fragment generated during this process was not returned for analysis.The overall length and width dimensions of the returned device, each considered a critical dimension per drawing no.45300, were assessed using digital caliper id: 011 and found to be within tolerance.As the broken forceps tip was bent at the breakage site, this event is most likely the result of user applied mechanical damage to the device during use, such as through prying/leveraging and/or torquing on the device during use.

• Brand Name: BONE REDUCTION FORCEPS, CURVED, POINTED
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11730927
• Report Number: 1220246-2021-02966
• Device Sequence Number: 3721410
• Product Code: MDM
• UDI-Device Identifier: 00888867052178
• UDI-Public: 00888867052178
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 06/29/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: BONE REDUCTION FORCEPS, CURVED, POINTED
• Device Catalogue Number: AR-8943-07
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/27/2021
• Supplement Report FDA Received Date: 06/29/2021
• Patient Sequence Number: 1