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	03/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the procedure when the customer cleaned the stripper, rust was seen.No patient injury reported.
Additional Manufacturer Narrative
Foreign post code (b)(4).Examination is not possible, as the device has not been returned, however a photograph was sent for evaluation.Examination of the photograph shows the device is contaminated with what appears to be human matter.The most common cause of rust formation on stainless steel is improper cleaning.Clean residual human matter from instrument using only recommended cleaners with a nuetral ph.Rinse thoroughly to remove all cleaner residues and dry completely.If the product is returned in the future the complaint can be reopened and evaluated.
Additional Manufacturer Narrative
One slotted tendon stripper was returned for evaluation.Visual assessment of the device identified two issues through the complaint.The first issue identified is the solder joint at the shaft to handle interface is discolored.The discoloration is not rust, but tarnishing of the silver solder.The tarnish is cosmetic only, and has no impact on the safety or function of the device.The second issue identified is voids in the solder joint where the shaft enters the handle.

• 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: 8535933
• Report Number: 1219602-2019-00441
• Device Sequence Number: 1743903
• Product Code: LXH
• UDI-Device Identifier: 03596010091093
• UDI-Public: 03596010091093
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 08/07/2019

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: 50755092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Initial Date Received by Manufacturer: 03/28/2019
• Supplement Date Received by Manufacturer: 05/10/2019; 08/05/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 05/13/2019; 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1