MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PERI-LOC 3.5MM T20 TI LCK SCR 36MM S-T; PLATE, FIXATION, BONE

Model Number	71865036
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the screw couldn't be removed manually from the plate.The event caused 45 minutes delay of surgery.
Additional Manufacturer Narrative
The devices, used in treatment, were not returned for evaluation and the reported event could not be confirmed.A review of complaint history did not reveal additional complaints for the listed batches for 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.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include surgical technique or device damaged during use.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 devices or additional information be received, the complaints will be reopened.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: PERI-LOC 3.5MM T20 TI LCK SCR 36MM S-T
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9426061
• Report Number: 1020279-2019-04307
• Device Sequence Number: 11190471
• Product Code: HRS
• UDI-Device Identifier: 03596010641335
• UDI-Public: 03596010641335
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,health profe
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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
• Operator of Device: Health Professional
• Device Model Number: 71865036
• Device Catalogue Number: 71865036
• Device Lot Number: 18AT97761
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 04/07/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1