MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JOURNEY UNI TIB TR INS SZ3-4/9MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71436134
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.It was reported that three universal insert spacer size 1-2 18 mm ((b)(4)), the tibial spacer block standard ((b)(4)) the journey ii xr tibial base implant impactor ((b)(4)) and the journey uni tibial trail insert size 3-4/ 9 mm ((b)(4)) were noticed cracked.The screw depth gauge ((b)(4)), meta-tan anti rotation bar (b)(4)), humeral ruler ((b)(4)), two screw driver release handle ((b)(4)), the journey dcf ap fem cut blk 4 ((b)(4)) the journey ii tka femoral trial left size 5 ((b)(4)) and 3.5 mm locking screw guide ((b)(4)) were noticed broken.No case involved.
Event or Problem Description
It was reported that during an inspection in the warehouse it was noticed that the journey uni tibial trail insert size 3-4/ 9 mm was cracked.No case involved.
Additional Manufacturer Narrative
H3, h6: the device, intended for use in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal any manufacturing or material abnormalities 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.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: JOURNEY UNI TIB TR INS SZ3-4/9MM
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11593500
• Report Number: 1020279-2021-02556
• Device Sequence Number: 17012708
• Product Code: HSX
• UDI-Device Identifier: 03596010588111
• UDI-Public: 03596010588111
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: 71436134
• Device Catalogue Number: 71436134
• Device Lot Number: 17KB01233
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1