MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PERI-LOC 3.5MM TI M-D TB PL 13H L; PLATE, FIXATION, BONE

Catalog Number	71861013
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/09/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to fracture of the device.
Additional Manufacturer Narrative
The associated peri loc plate was not returned for evaluation.Our investigation including a clinical investigation which concluded that all documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical investigation.Without the device for evaluation the root cause of the implant fracture cannot be concluded.The future impact to the patient beyond the revision cannot be determined.No further clinical/medical assessment is warranted at this time.Without the return of the actual product involved and no batch information available, our investigation of this report is inconclusive.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 3.5MM TI M-D TB PL 13H L
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7186521
• Report Number: 1020279-2018-00047
• Device Sequence Number: 13941203
• Product Code: HRS
• UDI-Device Identifier: 03596010635860
• UDI-Public: 03596010635860
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K083032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2018

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 Catalogue Number: 71861013
• Initial Date Received by Manufacturer: 01/09/2018
• Supplement Date Received by Manufacturer: 01/09/2018
• Initial Report FDA Received Date: 01/12/2018
• Supplement Report FDA Received Date: 05/17/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Weight: 80