MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BONE ANCHORS 3 W ARTHRO DEL SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2503-A
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during rotator cuff repair surgery the tendon anchors were not being grasped by tendon inserter (bone anchors 3 w arthro del system).The correct technique was being used, but the tendon inserter appeared to be mangled.The procedure was completed without delay using a s+n backup device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the returned device and noted the plastic is deformed and appears to have been melted.The trigger is protruding from the handle.Functional evaluation revealed the trigger is seized and cannot be depressed.The complaint was confirmed.Factors that could have contributed to the reported event include autoclave damage.Please refer to the instructions for use for recommendation on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No product identification information was provided and thus a manufacturing record review could not be conducted.A complaint history review concluded this was a repeat issue.

• Brand Name: BONE ANCHORS 3 W ARTHRO DEL SYSTEM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 10446294
• Report Number: 3003604053-2020-00087
• Device Sequence Number: 17147810
• Product Code: LXH
• UDI-Device Identifier: 00854501006173
• UDI-Public: 00854501006173
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K131635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2020

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: 2503-A
• Device Catalogue Number: 2503-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1