MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PERCUTANEOUS GUIDE BOLT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 71631024

Device Problem Failure to Align (2522)

Patient Problem No Information (3190)

Event Date 08/21/2018

Event Type  malfunction  

Event Description

It was reported that the instrumentation intra-operatively failed to align proximal femoral implants.

Manufacturer Narrative

The associated complaint devices were returned and evaluated.A visual inspection of the returned devices indicated surface damage and wear from use.These devices were manufactured ranging from four to eleven years ago.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A functional evaluation indicated that we were able to properly duplicate the surgical technique with all the mating components and found no issue with the alignment.All the mating components met the drawing specification and assembled with no issues.Based on the evidence available to us, we are unable to determine a possible issue with the devices; the need for corrective action is not indicated.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: PERCUTANEOUS GUIDE BOLT
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7870626
• MDR Text Key: 120100826
• Report Number: 1020279-2018-01771
• Device Sequence Number: 1
• Product Code: HSB
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71631024
• Device Lot Number: 07LM01806
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization