MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN PS HIGH FLEX XLPE SZ 3-4 9MM; NAIL, FIXATION, BONE

Model Number 71453211

Device Problem Unstable (1667)

Patient Problem Injury (2348)

Event Date 10/17/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to a joint instability.No further information is available yet.

Event Description

It was reported that a revision surgery was performed due to a joint instability.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that no clinical supporting documents were provided to conduct a thorough assessment of the reported issue.A review of complaint history did not reveal additional complaints for the listed batch.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.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes of this event could include inadequate device selection or a sizing issue.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: LGN PS HIGH FLEX XLPE SZ 3-4 9MM
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9313378
• MDR Text Key: 166127187
• Report Number: 1020279-2019-03985
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 00885556035252
• UDI-Public: 00885556035252
• Combination Product (y/n): N
• PMA/PMN Number: K071071
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/25/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 71453211
• Device Catalogue Number: 71453211
• Device Lot Number: 15BM11922
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: 10/28/2019
• Supplement Dates FDA Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention