MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 3.2MM GUIIDE PIN SLEEVE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71674532

Device Problem Mechanical Problem (1384)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2020

Event Type  Injury  

Event Description

It was reported that the lag screw drill sleeve was extremely difficult to remove from the 3.2 guide pin sleeve during surgery.The surgeon had to use other tools to remove it prior to drilling with the lag screw drill.No surgical delay or injury to the patient was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

Additional information: d4 and h4.The device, used treatment, was returned for evaluation.A visual inspection of the returned device confirms significant signs of wear and usage.There are some scratches, burrs and gouges in the device.This device was manufactured in 2015.A functional evaluation was conducted with the mating device returned with this device.The drill sleeve was not able to target correctly.A medical investigation was conducted and this case reports that during the procedure, the lag screw drill sleeve was extremely difficult to remove from the guide pin sleeve.Per email communication, different instrumentation was used to remove the guide pin sleeve from the lag screw sleeve, prior to drilling with the lag screw drill.There was no patient injury or delay reported.No further clinical assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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.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 complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: INTERTAN 3.2MM GUIIDE PIN SLEEVE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10795766
• MDR Text Key: 214990487
• Report Number: 1020279-2020-06246
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00885556389348
• UDI-Public: 00885556389348
• Combination Product (y/n): N
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/12/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/19/2015
• Device Model Number: 71674532
• Device Catalogue Number: 71674532
• Device Lot Number: 15KM02410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 12/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention