MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM LCP HOOK PLATE 3 HOLE; PLATE, FIXATION, BONE

Model Number 02.113.103

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

Patient Problems Pain (1994); Non-union Bone Fracture (2369); Physical Asymmetry (4573); Swelling/ Edema (4577)

Event Type  Injury  

Event Description

It was reported on unknown date that there was an open reduction and internal fixation of left intra-articular distal tibia and fibula pilon fracture.15 weeks post op: p/w increased left ankle pain and swelling.X-rays demonstrated displacement of the medial malleolus fracture and protein screw from the posterolateral plate.15 weeks post op: underwent left ankle revision with autograft and allograft due to nonunion.This report is for one (1) 3.5mm lcp hook plate 3 hole.This is report 2 of 5 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.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.

• Brand Name: 3.5MM LCP HOOK PLATE 3 HOLE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15649458
• MDR Text Key: 302168305
• Report Number: 8030965-2022-08569
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982034724
• UDI-Public: (01)10886982034724
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.113.103
• Device Catalogue Number: 02.113.103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX; UNK - SCREWS: CORTEX
• Patient Outcome(s): Required Intervention