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

Model Number STRIPPER, PIGTAIL HAMSTRING TENDON, 5MM

Device Problem Dull, Blunt (2407)

Patient Problem Laceration(s) (1946)

Event Date 04/12/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 290703680
• Report Number: 1220246-2022-04832
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00888867006911
• UDI-Public: 00888867006911
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other