MAUDE Adverse Event Report: ARTHREX, INC. PROBE, HOOK 3.4MM TIP W/5MM MARKINGS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	PROBE, HOOK 3.4MM TIP W/5MM MARKINGS
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2021
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a rotator cuff repair an ar-10010 probe hook, broke during the procedure.Additional information has been requested.
Additional Manufacturer Narrative
The complaint is not confirmed.One unpackaged ar-10010, batch 12077196 probe was received for investigation.Visual inspection under magnification identified no breakage to the device.Both the tip and overall shaft length met design specifications per drawing acd-10010, rev.1.It was assessed using micro-vu id: 654 that the shaft had bent approximately 9.14mm from the hook tip, proximal to the second distal-most laser marking.The shaft bend observed is consistent with user-applied mechanical forces via prying/leveraging the device during use.

• Brand Name: PROBE, HOOK 3.4MM TIP W/5MM MARKINGS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12032282
• Report Number: 1220246-2021-03286
• Device Sequence Number: 3800383
• Product Code: LXH
• UDI-Device Identifier: 00888867002364
• UDI-Public: 00888867002364
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: PROBE, HOOK 3.4MM TIP W/5MM MARKINGS
• Device Catalogue Number: AR-10010
• Device Lot Number: 12077196
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 08/11/2021
• Patient Sequence Number: 1