MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM TRL SHELL 52MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71363052
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inspection the tandem trl shell´s were found without threads.No case related, therefore, no patient involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
Additional information received by the reporter has identified that this event should be re-evaluated for mdr reporting.The new information states that the device is an old style that never had threads which does not suggest that the device malfunction or may cause any injury in the future, therefore, it was determined that this case does not meet the threshold for reporting and complaint criteria, therefore this is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
Event or Problem Description
It was reported that during inspection the tandem trl shell's were found without threads.These are old styles that never had threads.No case related, therefore, no patient involved.

• Brand Name: TANDEM TRL SHELL 52MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10497170
• Report Number: 1020279-2020-04409
• Device Sequence Number: 16866264
• Product Code: LXH
• UDI-Device Identifier: 03596010481658
• UDI-Public: 03596010481658
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2020

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: 71363052
• Device Catalogue Number: 71363052
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1