MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - PLATES; PLATE, FIXATION ,BONE

Device Problem Device-Device Incompatibility (2919)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2018, the patient had an open reduction and internal fixation of left distal radius.Patient had already undergone one procedure after her initial surgery for a screw removal that had backed out and become symptomatic.The patient had subsequently had a second screw from the distal radius plate that backed out and is causing her pain and continues to have a lot of pain over the left wrist.The patient also tried conservative therapy with minimal relief of symptoms.The mini c arm was then used to identify the plate and screws that were to be removed.The most ulnar distal locking screws were also removed and then the 3 shaft screws were removed.A freer was then used to elevate the plate from the distal radius and it was removed without complication.The screw holes were curetted.The fracture site about the radial styloid was identified and noted to be stable, there was no movement with stress to the distal radius.The mini-c arm was then used again to confirm that all hardware had been removed.On an unknown date, the patient fell and sustained a comminuted distal radius fracture and had intra-articular split with significant displacement.Her current position was unacceptable with significant diastasis of the scaphoid and lunate facets with dorsal angulation.On (b)(6) 2017, the patient underwent open reduction, internal fixation left comminuted distal radius fracture greater than three parts using volar plating.A three holes volar locking plate from synthes was placed over the volar aspect of the fracture fragments locking the fracture fragments underneath of the fracture.On (b)(6) 2017, the patient underwent open reduction and internal fixation of her left wrist.After 1 of her sessions of physical therapy, the patient had significant increase of swelling and pain.Upon review of radiographs, it did appear that 1 of the screws had backed out of the plate a little bit.There was a removal of a loosened screw due to possible injury and irritation of tendons.This complaint involves two (2) devices.This is 1 of 2 for report (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Received x-ray reviewed, the complaint description can be confirmed.Not possible to identify the root cause for the reported problem without having the complained part available for investigation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Update: actual device was not returned; customer quality will conduct investigation based on the images provided for the product code: unk.Plate / locking screw, lot #: unk, quantity: 2.

Manufacturer Narrative

Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.E1: legal attorney.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNK - PLATES
• Type of Device: PLATE, FIXATION ,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9297227
• MDR Text Key: 184901259
• Report Number: 2939274-2019-62040
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR