MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS ART ISRT TRL SZ 1-2 9MM LT; PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY

Model Number	74035221
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an inspection in the warehouse it was noticed the failure of defective devices.The journey ii bcs articular insert size 1-2 9 mm left ((b)(4)), the journey ii bcs articular insert size 1-2 9 mm right ((b)(4)), two universal insert spacer size 1-2 18 mm ((b)(4)), journey ii cr locking femoral impactor bumper right ((b)(4)), journey uni tibia insert size 1-2/8 mm ((b)(4)), journey uni tibia trial size 5-6/8 mm ((b)(4)),journey uni tibia trial size 3-4/8 mm ((b)(4)), three honeycomb ((b)(4)), journey ii bcs articular insert trial size 1-2 10 mm right ((b)(4)), the journey ii bcs articular insert trial size 1-2 10 mm left ((b)(4)) and the journey ii bcs articular insert trial size 1-2 12 mm left ((b)(4)) were noticed cracked.Two compression screw hex driver ((b)(4)) and screwdriver release handle ((b)(4)) were noticed broken.No case involved.
Additional Manufacturer Narrative
The device, intended for use in treatment, was not returned for evaluation.Therefore, the product analysis and the reported event could not be confirmed at this time.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.A review of the complaint history on the listed part revealed no prior complaints for the listed failure mode with the same batch number.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.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 warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JRNY II BCS ART ISRT TRL SZ 1-2 9MM LT
• Common Device Name: PROSTH, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONST, CEMENTED, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116 ; UK 38116
• MDR Report Key: 11593400
• Report Number: 1020279-2021-02527
• Device Sequence Number: 3511550
• Product Code: JWH
• UDI-Device Identifier: 00885556156735
• UDI-Public: 00885556156735
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2021

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: 74035221
• Device Catalogue Number: 74035221
• Device Lot Number: 20CB02275
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1