MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM; PLATE,FIXATION,BONE

Catalog Number 241.351

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Hypoesthesia (2352); Non-union Bone Fracture (2369); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Event occurred on an unknown date in 2020.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.(b)(4).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

Patient initiated complaint: on (b)(6) 2019, the patient underwent bunion surgery and a plate was placed on his big toe.The patient experienced numbness in toe postoperatively and after evaluation by physician, it was found that there was non-union and a broken plate.It was reported that on (b)(6) 2020, the patient underwent a surgery due to a non-union and a broken plate.There is no further information available.Concomitant device reported: unknown screws (part # unknown, lot # unknown, quantity unknown).This report is for one (1) lcp one-third tubular plate with collar 5 holes/57mm.This is report 1 of 2 for (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.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

Updated event description: it was reported that on (b)(6) 2020 underwent a surgery due to a non-union and a broken plate.On (b)(6) 2019, the patient had a bunion surgery and a plate was placed on his big toe.The patient experienced numbness in toe postoperatively and after evaluation by physician found that there was non-union and a broken plate.On (b)(6) 2020 patient went to see why its still so swollen and pain was almost unbearable and found plate and screw broken.Concomitant device reported: unknown screws (part#: unknown, lot#: unknown, quantity: unknown).

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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: LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM
• 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: 10393085
• MDR Text Key: 203124221
• Report Number: 2939274-2020-03420
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K011335
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 241.351
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: LOCKING; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention