MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII ADJUSTABLE ANKLE CLAMP; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71440444
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, a gii adjustable ankle clamp is broken.It is unknown whether this problem was noticed in a surgical environment or not; therefore, patient involvement has not been confirmed.
Additional Manufacturer Narrative
G3, h2, h3, and h6: the device, intended for use in treatment, was returned for evaluation.A visual inspection of the gii adjustable ankle clamp confirms the device broke into several pieces.All pieces were returned for evaluation.The device shows significant signs of wear/usage.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII ADJUSTABLE ANKLE CLAMP
• 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: 12606252
• Report Number: 1020279-2021-07509
• Device Sequence Number: 16497655
• Product Code: HRY
• UDI-Device Identifier: 03596010215550
• UDI-Public: 03596010215550
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• 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): 10/29/2021

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 Expiration Date: 02/02/2014
• Device Model Number: 71440444
• Device Catalogue Number: 71440444
• Device Lot Number: 04AM09123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1