MAUDE Adverse Event Report: SMITH & NEPHEW, INC. R3 0DEG 36MM TRIAL 52MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	71365252
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trial broke while removing it.All pieces were retrieved from inside the incision.
Additional Manufacturer Narrative
The associated complaint device was not returned.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: R3 0DEG 36MM TRIAL 52MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8882999
• Report Number: 1020279-2019-03006
• Device Sequence Number: 2716564
• Product Code: LXH
• UDI-Device Identifier: 03596010599544
• UDI-Public: 03596010599544
• Combination Product (Y/N): N
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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 Catalogue Number: 71365252
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 08/12/2019
• Supplement Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1