MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX AR-600,HANDPIECE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	ARTHREX AR-600,HANDPIECE
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/26/2020
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 during a humerus osteosynthesis procedure, when the surgeon was taking off the battery housing, ar-600lbh, off of the handpiece, ar-600, he accidentally activated the handpiece, injuring his thumb.Due to this injury, the surgeon then dropped the handpiece and broke the ar-600lbh.The surgeon was attended to and the case was completed without any adverse effect to the patient, as a new handpiece was used.
Additional Manufacturer Narrative
Complaint not confirmed.During device functioning, a known good battery housing, battery and attachment were assembled to the device, since the returned battery housing was returned damaged/broken.When powering on, the device worked as intended with no issues.The locking mechanism for the battery was checked and it was functioning as intended.The most likely cause is stated in the complainant's narrative, that the device was accidentally activated causing the injury.

• Brand Name: ARTHREX AR-600,HANDPIECE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10184293
• Report Number: 1220246-2020-01913
• Device Sequence Number: 11445517
• Product Code: HWE
• UDI-Device Identifier: 00888867110175
• UDI-Public: 00888867110175
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2020

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: ARTHREX AR-600,HANDPIECE
• Device Catalogue Number: AR-600
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 06/23/2020
• Supplement Report FDA Received Date: 08/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other