MAUDE Adverse Event Report: ARTHREX, INC. STRIPPER, PIGTAIL HAMSTRING TENDON, 5MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	STRIPPER, PIGTAIL HAMSTRING TENDON, 5MM
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/12/2022
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
On 04/12/2022, it was reported by a sales representative via sems that a ar-1278p tendon stripper is dull.This was discovered during an unknown case when the device was found to not be sharp.A second incision was made due to the lack of sharpness.
Additional Manufacturer Narrative
Complaint not confirmed.Upon visual inspection inspection, no problem was noted to the devices.Upon functional testing, the devices were found to be dull.The cause of this remains undetermined.

• Brand Name: STRIPPER, PIGTAIL HAMSTRING TENDON, 5MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 14270271
• Report Number: 1220246-2022-04832
• Device Sequence Number: 5703457
• Product Code: LXH
• UDI-Device Identifier: 00888867006911
• UDI-Public: 00888867006911
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 08/03/2022

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: STRIPPER, PIGTAIL HAMSTRING TENDON, 5MM
• Device Catalogue Number: AR-1278P
• Device Lot Number: 47322145
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown