MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNKN PERI-LOC AND PERI-LOC VLP IMPL; PLATE, FIXATION, BONE

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 06/22/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case-(b)(4).Postal code (b)(6).Mehta, n., graham, s., lal, n., wells, l., giotakis, n., nayagam, s., & narayan, b.(2021).Fine wire versus locking plate fixation of type c pilon fractures.European journal of orthopaedic surgery & traumatology, 1-8.Doi: doi.Org/10.1007/s00590-021-03048-3.

Event Description

On the literature article named "fine wire versus locking plate fixation of type c pilon fractures", the authors of the study reported that, after bone healing, one patient that was originally treated with an orif system for a type c pilon fracture developed an unspecified condition, requiring an arthroscopic diagnosis.The outcome of this diagnosis was not reported.No further information was received.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded.In addition, the physician referenced in the abstract provided an analysis of all the attached images.Therefore, no further interpretation of the attached images is required.No further medical assessment is warranted at this time.Should any additional relevant clinical information be provided, this complaint would be re-assessed.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.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.We consider this investigation closed.Note, selected date of occurrence is paper publication; actual event date is unknown.

• Brand Name: UNKN PERI-LOC AND PERI-LOC VLP IMPL
• Type of Device: 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: 12737786
• MDR Text Key: 279579974
• Report Number: 1020279-2021-07765
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/02/2021
• Supplement Dates Manufacturer Received: 11/24/2021
• Supplement Dates FDA Received: 11/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other