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

Catalog Number	013554
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during the manipulation to pick up the tendon in the patient's body, the stripper tip of about 0.5 cm broke off.The broken off part was not removed.The patient feels fine.An additional tool removal operation is not planned.A backup device was available to complete the procedure with no delay or patient injuries.
Additional Manufacturer Narrative
One 013554 slotted tendon stripper device was used for treatment and returned for evaluation.This is a two year old reusable instrument.The complaint stated: ¿during the manipulation to pick up the tendon in the patient's body, the stripper tip of about 0.5 cm broke off.¿ this allegation was confirmed.One spiral is fractured across the entire configuration.There is bio matter and staining apparent on the fractured edge.Staining indicates that the stripper curl may have had a hairline fracture prior to the break reported here.There is a crease line where potential for a second fracture was noted.There a bow over the length of the shaft.The shaft is bent slightly downward from the handle.Per instructions for use: ¿these instruments are designed for repeated use with proper care and handling.As with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument.Excessive forces applied to the instrument can result in the instrument¿s failure.Do not use these instruments as levers for manipulating hard tissue or bone.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 edges.¿ no root cause related to the manufacture of the device was confirmed.Product met specifications upon release to 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: 8816254
• Report Number: 1219602-2019-00858
• Device Sequence Number: 14254482
• Product Code: LXH
• UDI-Device Identifier: 03596010091093
• UDI-Public: 03596010091093
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2019

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: 50668292
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR