MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM UNI CONV TRL 0MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71367900
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a thr surgery, the inside snap ring of a tandem uni conv trl 0mm was broken and would not stay on the trial neck.Incident occurred outside the patient.Surgery was resumed, with a delay of less than or equal to 30 minutes, with the same device.Patient was not injured as consequence of this problem.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
G4, h1, h2: further review of this case indicates this is a duplicate report.The event in this report has been already reported under complaint number (b)(4) with fda reference no.1020279-2021-08299.All further communication for this event will be managed in case mentioned above, including the results of our investigation.We respectfully request fda to close this case as a duplicate and refer to the referenced case above.

• Brand Name: TANDEM UNI CONV TRL 0MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin; austin, TX 78735 ; 5123913905
• MDR Report Key: 13101513
• Report Number: 1020279-2021-08924
• Device Sequence Number: 4697034
• Product Code: LXH
• UDI-Device Identifier: 03596010481733
• UDI-Public: 03596010481733
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2022

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: 71367900
• Device Catalogue Number: 71367900
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 01/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown