MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0DEG 28MM TRIAL 52MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	71360552
Medical Device Problem Codes	Break (1069); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the r3 0deg 28mm trial 50mm, the r3 0deg 28mm trial 52mm, the r3 0deg 28mm trial 54mm, the r3 0deg 28mm trial 56mm, and the r3 0deg 28mm trial 58mm were found to be scratched, and had broken locking tabs.No case reported; therefore, there was no patient involvement.
Additional Manufacturer Narrative
H11: d1 and d4.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned r3 0deg 28mm trial 52mm confirms the device has multiple scratches/gouges in the plastic.The locking tabs are also broken, rendering the device inoperable.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.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.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.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: R3 0DEG 28MM TRIAL 52MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12450281
• Report Number: 1020279-2021-06764
• Device Sequence Number: 16955379
• Product Code: LXH
• UDI-Device Identifier: 03596010598875
• UDI-Public: 03596010598875
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 10/12/2021

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: 71360552
• Device Catalogue Number: 71360552
• Device Lot Number: 20CDS0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Initial Date Received by Manufacturer: 08/18/2021
• Supplement Date Received by Manufacturer: 08/18/2021; 10/08/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 09/09/2021; 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1