MAUDE Adverse Event Report: SMITH & NEPHEW, INC. WIRE TENSIONER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71070341
Medical Device Problem Codes	Break (1069); Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during surgery a wire tensioner did not tension and broke outside of the patient.The procedure was completed without delay using a s+n back-up device.Patient was not harmed.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
The information received was re-evaluated for mdr notification and it was determined that this case does not meet the threshold for notification as smith-nephew is not the legal manufacturer.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and an additional report will be submitted outlining the details of the event and our investigations.

• Brand Name: WIRE TENSIONER
• 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, TX 78735 ; 5123913905
• MDR Report Key: 13671298
• Report Number: 1020279-2022-01030
• Device Sequence Number: 5275837
• Product Code: LXH
• UDI-Device Identifier: 08033201842072
• UDI-Public: 08033201842072
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K093047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2022

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: 71070341
• Device Catalogue Number: 71070341
• Device Lot Number: 18KP03054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 04/19/2022
• 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