MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PERI-LOC 4.5MM T25 TI LCK SCR 46MM S-T; PLATE, FIXATION, BONE

Model Number 71867046

Device Problem Fitting Problem (2183)

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

Event Date 03/04/2021

Event Type  Injury  

Event Description

It was reported that during surgery, while locking the screw, the screw passed the screw hole on the plate.The operation was finished using the same screw, without surgical delay.The patient was not harmed beyond the described event.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, a review of this complaint case revealed there were no patient injuries reported.The operation was finished using the same screw.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.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 complaint history did not reveal additional complaints for the listed batch.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible probable cause could include but not limited to procedural variance or user error.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.We consider this investigation closed.

• Brand Name: PERI-LOC 4.5MM T25 TI LCK SCR 46MM S-T
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11612109
• MDR Text Key: 243722538
• Report Number: 1020279-2021-02647
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 03596010641595
• UDI-Public: 03596010641595
• Combination Product (y/n): N
• PMA/PMN Number: K083032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71867046
• Device Catalogue Number: 71867046
• Device Lot Number: 18HT07726
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention