MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PERI-LOC 4.5MM T25 TI LCK SCR 56MM S-T; PLATE, FIXATION, BONE

Model Number	71867056
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during trauma surgery, after drilling and inserting several screws into the screw holes on the plate, one screw did not seat properly.The peri-loc 4.5 mm t25 titanium locking screw 56 mm self-tapping seemed to keep proceeding, although there was slight resistance during inserting, so the surgeon felt the screw might not stop and its screw head seemed to almost reach the bone when confirming image.The peri-loc 4.5 mm t25 titanium locking screw 56 mm self-tapping was removed and compared its screw head with other's screw head, but significant difference was not found.The procedure was completed after inserting other screws into other screw holes on the plate.The peri-loc 4.5 mm titanium lat dist femur plate 6h l 155 mm was implanted and left in the patient.The procedure was finished with a surgical delay of 10 minutes.The patient was not harmed beyond the reported event.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device has signs of damage from attempted use.The device was manufactured in 2019.The clinical/ medical investigation concluded that the two undated, unlabeled x-rays provided confirm the report.However, based on the product evaluation of the screw, excessive torque on the screw during insertion likely caused the reported event.According to the report, the surgeon was able to complete the procedure by inserting other screws into other screw holes on the plate and the peri-loc 4.5mm titanium lat dist.Femur plate 6h l 155mm was implanted and left in the patient.Since it was reported the procedure completed with a surgical delay of 10 minutes and there was no harm to the patient; no further clinical/medical assessment is warranted at this time.Should an additional medical information be provided, this complaint will be e-assessed.The dimensional inspection found the device to be within specification.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 do not have 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.The potential probable cause for this event is likely a procedural error.Based on this investigation, the need for corrective action is not indicated.Should 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 56MM S-T
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10426649
• Report Number: 1020279-2020-04041
• Device Sequence Number: 2938419
• Product Code: HRS
• UDI-Device Identifier: 03596010641649
• UDI-Public: 03596010641649
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K083032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2021

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: 71867056
• Device Catalogue Number: 71867056
• Device Lot Number: 19AT14701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Initial Date Received by Manufacturer: 07/20/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 08/19/2020
• Supplement Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PERI-LOC 4.5 MM TI L-D FEM PL 6H L 155 MM; PERI-LOC 4.5 MM TI L-D FEM PL 6H L 155 MM
• Outcome Attributed to Adverse Event: Other; Required Intervention