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

Catalog Number 71674532

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2019

Event Type  malfunction  

Event Description

It was reported that there was trouble getting the guide pin sleeve into the lag screw drill sleeve.A delay of over 30-min was reported.No injury reported.A back up device was available.

Manufacturer Narrative

The associated devices were returned and evaluated.A visual inspection of the returned devices could not confirm the stated failure mode.The devices were manufactured in 2015 and exhibit signs of extensive wear/usage.The functional evaluation confirmed the stated failure mode.The pin sleeve would not mate with the drill sleeve as intended.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.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 road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: sarah freestone ; 1450 brooks road; memphis, TN 38116 ; 0447940038
• MDR Report Key: 8512781
• MDR Text Key: 141897436
• Report Number: 1020279-2019-01573
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00885556389348
• UDI-Public: 00885556389348
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K122170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: 71674532
• Device Lot Number: 15JM13926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 09/20/2019
• Supplement Dates FDA Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1