MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM TRL SHELL 45MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71363045
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during instrument inspection, it was noticed that the 45mm tandem trial shell and the tandem straight trial handle were stripped, not allowing them to attach to each other.Back-up devices from smith and nephew were available.Surgery was not delayed.The patient was not harmed.
Additional Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.A visual inspection confirms the trail has several scratches, burrs and deep gouges.Also the threads on the trial are damaged.There is no lot number on this device.The device shows significant signs of wear/usage.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.

• Brand Name: TANDEM TRL SHELL 45MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10168073
• Report Number: 1020279-2020-02512
• Device Sequence Number: 2102069
• Product Code: LXH
• UDI-Device Identifier: 03596010481580
• UDI-Public: 03596010481580
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2020

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: 71363045
• Device Catalogue Number: 71363045
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 06/18/2020
• Supplement Report FDA Received Date: 08/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TANDEM STR THREADED HNDLE (CN: 71362804); TANDEM STR THREADED HNDLE (CN: 71362804)