MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN POS FEM WDG 5MM SZ5-6 LNG; PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL

Model Number	71421805
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery when trying to assemble the 5 mm posterior augment the screw would not engage and lock down the augment.It was tried for at least 20 minutes.A back up device was used and it went down easily.It was found that the that the screw was different in the second package.It was both smaller in width and length.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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 POS FEM WDG 5MM SZ5-6 LNG
• Common Device Name: PRSTHSS,KN,PTLLFMRTBL,SM-CNSTRND,CMNTD,PLYMR/MTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10173177
• Report Number: 1020279-2020-02596
• Device Sequence Number: 19371453
• Product Code: JWH
• UDI-Device Identifier: 03596010545398
• UDI-Public: 03596010545398
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K041106
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

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: 71421805
• Device Catalogue Number: 71421805
• Device Lot Number: 19FSM0901
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1