MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II ART ISRT TRL SZ 7-8 9MM LT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Catalog Number	74035281
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the item broke in half upon impaction.No harm to the patient was recorded.No delay and no broken piece fell into the patient.Sn backup device was available.
Additional Manufacturer Narrative
The associated complaint device was returned for evaluation.The visual inspection of the returned device confirms the stated failure.The articular trial insert is broken in half.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Our investigation did not determine a specific cause of the failure; however the device shows significant signs of use.This device was manufactured in 2013.We recommend that all re usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• Brand Name: JRNY BCS II ART ISRT TRL SZ 7-8 9MM LT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8914954
• Report Number: 1020279-2019-03099
• Device Sequence Number: 18961291
• Product Code: JWH
• UDI-Device Identifier: 00885556157336
• UDI-Public: 00885556157336
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111711
• 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): 11/16/2019

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: 74035281
• Device Lot Number: 13DAP0635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 11/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1