MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PERI-LOC VLP 3.5MM X 44MM CRTX SCRW S-T; PLATE, FIXATION, BONE

Model Number	71821344
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Injury (2348)
Date of Event	11/11/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure the nail was placed and when it was inspected using the image intensifier, this showed the nail was bent.Device was removed using forceps.The procedure was completed using a smith & nephew backup device.There was no further harm to the patient.The patient is stable.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A clinical evaluation indicated that there have been three unsuccessful attempts to obtain clinical/medical documentation.Per communication the bent nail was removed using forceps.The procedure was completed using a backup with no patient injuries reported.Since no patient harm is being alleged and no further harm is anticipated, no further assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.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 revealed this failure mode was previously identified.Factors and/or some potential probable causes that could contribute to the reported event include but not limited to improper loading and off-label use, improper material selection, and plate design inadequate for intended use.Without the return of the actual product involved and no patient medical records, our investigation of this report is inconclusive.

• Brand Name: PERI-LOC VLP 3.5MM X 44MM CRTX SCRW S-T
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9457791
• Report Number: 1020279-2019-04387
• Device Sequence Number: 3077490
• Product Code: HRS
• UDI-Device Identifier: 03596010625571
• UDI-Public: 03596010625571
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K062216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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
• Operator of Device: Health Professional
• Device Model Number: 71821344
• Device Catalogue Number: 71821344
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention