MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII PRIM P/S COLLET W/THMBSCRW; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71440467
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tkr surgery, a genesis ii prim p/s collet w/thmbscrw screw sheared off.It remains unknown when this failure was noticed.It is also unknown how this procedure was completed and whether it caused a surgical delay.
Additional Manufacturer Narrative
G3, h2, h3, and h6: the device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the sheared off screw was confirmed.The shipping information was provided and all efforts were made to locate the device but we have no evidence that it was ever received by the complaint investigation team for evaluation.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.G2: report source update.
Event or Problem Description
It was reported that, during a tkr surgery, a genesis ii prim p/s collet w/thmbscrw screw sheared off.Surgery was completed with a backup device, without any delay.As this was noticed during set up, there was no patient involvement.

• Brand Name: GII PRIM P/S COLLET W/THMBSCRW
• 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: 12166178
• Report Number: 1020279-2021-05949
• Device Sequence Number: 4215003
• Product Code: HRY
• UDI-Device Identifier: 03596010443076
• UDI-Public: 03596010443076
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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 Expiration Date: 05/16/2016
• Device Model Number: 71440467
• Device Catalogue Number: 71440467
• Device Lot Number: 06CM08920
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 09/06/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1