MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN TIBIAL CUTTING BLOCK RIGHT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71434332
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a trochar pin was found attached, presumably cold welded, to a lgn tibial cutting block right and cannot be removed.It is unknown whether this event happened during surgery or not; therefore, patient involvement cannot be confirmed.
Additional Manufacturer Narrative
Section b5 was updated with the new information received.Internal complaint reference number: (b)(4).
Event or Problem Description
It was reported that during a revision of tka (unknown if from s+n), a trochar pin was found attached, presumably cold welded, to a lgn tibial cutting block right and can't be removed.This incident led to a surgical delay of fewer than 30 minutes, and it was reported that a smith and nephew backup device was available to conclude the procedure.No patient injury was reported due to this event.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the failure mode was confirmed.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LGN TIBIAL CUTTING BLOCK RIGHT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11849896
• Report Number: 1020279-2021-04464
• Device Sequence Number: 19781339
• Product Code: HRY
• UDI-Device Identifier: 03596010549822
• UDI-Public: 03596010549822
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2021

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: 71434332
• Device Catalogue Number: 71434332
• Device Lot Number: 06BM05197
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 06/08/2021; 10/07/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/08/2021; 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1