MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JII UNI INS TRIAL SZ 1-2 8MM; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71935100

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, in surgery (journey uni with cori) the journey i uni medial insert trial sz 1-2 8mm trial insert was chipped up.Instruments were inside the patient.The procedure was successfully completed without delay using the same device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device, used in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is chipped, damaged, broken and has signs of wear and tear from use.Per complaint details, it was noted during a j-uni/cori procedure that the ¿journey i uni medial insert trial sz 1 2 8mm trial insert was chipped¿.Reportedly, after removal of the broken trial/piece with a kocher clamp, the procedure was successfully completed without delay using the same device without patient injury or other complications reported.Since no patient injury/harm or surgical delay was alleged and the procedure was successfully completed, no further medical assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.A review of the risk management file revealed this failure mode was previously identified.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: JII UNI INS TRIAL SZ 1-2 8MM
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11016006
• MDR Text Key: 221711204
• Report Number: 1020279-2020-07472
• Device Sequence Number: 1
• Product Code: HSX
• UDI-Device Identifier: 00885556577639
• UDI-Public: 00885556577639
• Combination Product (y/n): N
• PMA/PMN Number: K152315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71935100
• Device Catalogue Number: 71935100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention