MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS CONST ISRT TRL S5-6 10MM RT; PRSTHS, KN, PTLLFMRTBL, SM-CNSTRND, CMNTD, PLYMR/MTL

Catalog Number	74034252
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the poly trial snapped in half.It broke inside the patient, nothing was left in the incision, all pieces were recovered.S and n back up device was available.No delay or injury reported.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the insert trial confirms the device fractured into two pieces.Both pieces were returned for evaluation.Also there are several burrs/gouges in the plastic.The device was manufactured in 2013.The insert trail exhibits signs of significant use and wear.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.This investigation could not verify or identify any evidence of product contribution to the reported problem.Should additional information be received, the complaint will be reopened.

• Brand Name: JRNY II BCS CONST ISRT TRL S5-6 10MM RT
• Common Device Name: PRSTHS, KN, PTLLFMRTBL, SM-CNSTRND, CMNTD, PLYMR/MTL
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9529725
• Report Number: 1020279-2019-04628
• Device Sequence Number: 411840
• Product Code: JWH
• UDI-Device Identifier: 00885556003091
• UDI-Public: 00885556003091
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K140555
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020

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: 74034252
• Device Lot Number: 13FBG0119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 01/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1