MAUDE Adverse Event Report: ARTHREX, INC. 4.85MM SUCTION SIDEBITER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	4.85MM SUCTION SIDEBITER SHAFT
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2019
Type of Reportable Event	Serious Injury
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 after surgery when examining the instruments, it was noticed that the distal end of the punch is missing.Update 07-jun-2019: it is unknown where the fragment broke-off and where it is currently.It cannot be excluded that it still remains in patient.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation revealed the end cap has dissociated from the outer tube.There were no other signs of breakage or damage to the remaining components.From the device evaluation, its unknown how the tip was disassociated from the outer tube.

• Brand Name: 4.85MM SUCTION SIDEBITER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8734582
• Report Number: 1220246-2019-01163
• Device Sequence Number: 2637227
• Product Code: LXH
• UDI-Device Identifier: 00888867040786
• UDI-Public: 00888867040786
• 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: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019

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: 4.85MM SUCTION SIDEBITER SHAFT
• Device Catalogue Number: AR-6701-48
• Device Lot Number: 10321748
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 09/13/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other