MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS ART ISRT TRL SZ 1-2 10MM LT; PROSTH,KNEE,PATFEMTIB,SEMICONSTR,CEMENT,POLY/MET/POLY

Model Number	74035222
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, instruments inside the patient, the insert trial was broken.Unknown how the procedure finished.Surgical delay less than 30 minutes.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection confirms the trial has deep gouges, nicks and has several chips in the plastic.Also the visual confirms a piece of the device is missing.The piece was not returned with the device.This device shows significant signs of wear/usage.This device was manufactured in 2016.A medical investigation was conducted and this case reports the trial insert broke while inside the patient.Per email communication, "the doctor judged there were no pieces left inside the body before the wound was closed" and the procedure was completed with minimal delay, using a different sizing device.Since no patient harm is alleged, no further clinical assessment is warranted.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of risk management files found that the reported failure was documented appropriately.The device is a reusable instrument that can be exposed to numerous surgeries and cleaning cycles.As plastics are vulnerable and crack may have initiated during use and possible causes could be due to the heating and cooling associated with autoclaving or prolonged use.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.Should 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.
Event or Problem Description
It was reported that during surgery, while the instrument was inside the patient, the insert trial was broken.All the pieces were recovered.The procedure was completed by using a different sizing device with a delay of fewer than 30 minutes.There was no serious harm to the patient.

• Brand Name: JRNY II BCS ART ISRT TRL SZ 1-2 10MM LT
• Common Device Name: PROSTH,KNEE,PATFEMTIB,SEMICONSTR,CEMENT,POLY/MET/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10789397
• Report Number: 1020279-2020-06196
• Device Sequence Number: 11564241
• Product Code: JWH
• UDI-Device Identifier: 00885556156780
• UDI-Public: 00885556156780
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 74035222
• Device Catalogue Number: 74035222
• Device Lot Number: 16JAP2724
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 11/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention