MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PERI-LOC VLP 3.5MM X 26MM LCK SCRW S-T; PLATE, FIXATION, BONE

Model Number	71821226
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	09/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that, during an internal fixation surgery (osteosynthesis of tibial plates), a peri-loc vlp 3.5mm x 26mm lck screw s-ts was used and it was placed normally when it was going to be locked, the screw instead of locking it was rolled (not adjusted) in the placed plate and in no way could the screw be removed, immediately the specialist verified that the technique carried out was the correct one and indeed they were the correct steps of the placement of the material for which he decided to leave the screw inside the plate.Surgery was completed with the same device, however another screw was used in order to get the desired fixation.The plate system was correctly implanted, after a delay less than or equal to 30mins.Patient was not harmed as consequence of this problem.
Additional 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, smith and nephew has not received adequate clinical information nor the device, therefore, a thorough medical investigation cannot be rendered nor can the root cause of the reported failure be determined.Based on the information provided, the specialist verified that the technique carried out was the correct one and indeed they were the correct steps of the placement of the material for which he decided to leave the screw inside the plate.Per subsequent e-mail, the screw was not tight to the plate.It was reported, the surgery was completed with the same device; however, another screw was used to obtain the desired fixation.According to the report, the plate system was correctly implanted, with a delay less than or equal to 30 minutes.Since it was reported there was no harm alleged to this patient, no further clinical/medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed device for the same failure mode.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 causes could include but not limited to surgical technique used, size of device or user/procedural variance.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: PERI-LOC VLP 3.5MM X 26MM LCK SCRW S-T
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 12611770
• Report Number: 1020279-2021-07523
• Device Sequence Number: 16474079
• Product Code: HRS
• UDI-Device Identifier: 03596010607164
• UDI-Public: 03596010607164
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K062216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71821226
• Device Catalogue Number: 71821226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female