MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LID FOR OUTER CASES; TRAY, SURGICAL, INSTRUMENT

Model Number 71129402

Device Problem Component Missing (2306)

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

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

the device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The handles on the device are broken, rendering the device inoperable.The device was manufactured in 2012 and shows signs of extensive use.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 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.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

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Event Description

It was reported that during a field inspection the ipg mis dcf ap ct blk 3 was noted to be rusty and discolored, the extramedulary alignment rod was broken, the gii quick connect handle dented and did not retract, the ipg ps high flex impctr hd 1-2 gii ps high flex impctr hd 3-8, gii tibial base impactor, gii narrow pcl retractor, 11mm gns ii tibial drill with burrs and gouges and outer housing cap with one component missing and broke.No case reported; therefore, there was no patient participation.

Manufacturer Narrative

After further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that, during a field inspection, the the lid for outer cases were found with one component missing and broke.No case reported; therefore, there was no patient participation.However after further clarification and information received, it was determined that the issue does not meet the criteria to be reportable.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The handles on the device are broken, rendering the device inoperable.The device was manufactured in 2012 and shows signs of extensive use.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 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.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LID FOR OUTER CASES
• Type of Device: TRAY, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11646826
• MDR Text Key: 244843378
• Report Number: 1020279-2021-02830
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 03596010415103
• UDI-Public: 03596010415103
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71129402
• Device Catalogue Number: 71129402
• Device Lot Number: 12FCM0032
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1