MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TENDON STRIPPER SLOTTED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	013554
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure the stripper tendon was broken.No back up device was available, no patient injuries or delay were reported.
Additional Manufacturer Narrative
Examination is not possible, as the device has not been returned, however a photograph was provided.The photos show the distal end of the tendon stripper has broken off.The device has been in the field for over 11 years without previous issues.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force being applied during use.The instruction for use was reviewed and was found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
One slotted tendon stripper was returned for evaluation.Visual assessment confirmed the reported complaint of breakage.The a portion of the distal tip has broken off and was not returned for examination.The device is over 11 years old and shows normal wear and tear.The shaft is bent.The condition of the device indicates it was likely subjected to excessive force causing the tip breakage.Per the devices instructions for use¿excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edge¿.There were no indications that would suggest that the devices did not meet product specifications upon release into distribution.

• Brand Name: TENDON STRIPPER SLOTTED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8624269
• Report Number: 1219602-2019-00573
• Device Sequence Number: 13917893
• Product Code: LXH
• UDI-Device Identifier: 03596010091093
• UDI-Public: 03596010091093
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/14/2019

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 Catalogue Number: 013554
• Device Lot Number: 50245014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 06/24/2019; 10/11/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 06/25/2019; 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1