MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: 3.5 MM RECONSTRUCTION PLATE/SCREWS; PLATE, BONE

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

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: lee, c., iliopoulos, e., and yousaf, s.(2021), the timing of closed unstable ankle fracture fixation and major wound complications ¿ an observation from a uk major trauma centre, journal of pakistan medical association, vol.71, no.8 (suppl.5), pages 1-6 (united kingdom).A retrospective cohort study was performed at a uk major trauma centre to identify whether timing of surgical fixation of closed unstable ankle fracture affected the rate of major wound complications.Consecutive cases of unstable ankle fractures treated with open reduction internal fixation (orif) between march 2014 to december 2016 were included in this retrospective cohort study.A total of 235 consecutive cases were included.There were 108 patients in the early fixation group, and 127 patients in the delayed fixation group.The average age was 48±19.6 years with a range of 18 to 93 years.Implants used were (dcp, lc-dcp, recon plate) or distal fibular locking plate (depuy synthes distal fibula locking compression plate (lcp) or smith and nephew 3.5mm peri-loc vlp).Data were collected from 2018 onwards allowing a minimum follow-up of 2 years.The following complications were reported as follows: an 88-year-old female patient was implanted with a synthes fibula locking plate.She had major wound complications (deep wound infections, wound dehiscence).An 82-year-old female patient was implanted with a synthes recon plate.She had major wound complications (deep wound infections, wound dehiscence).A 49-year-old female patient was implanted with a synthes locking plate.She had major wound complications (deep wound infections, wound dehiscence).A 19-year-old female patient was implanted with a synthes locking plate.She had major wound complications (deep wound infections, wound dehiscence).The article does not provide sufficient information to identify which device manufacturer is associated with these adverse events.7 patients had fixation failure and revision orif.12 patients had symptomatic metalwork causing irritation with subsequent metal work removal.Major wound complications (deep wound infections, wound dehiscence) occurred in 7 patients.Six of these patients had deep surgical site infection and required wound debridement, washout and removal of metal.One patient was re-admitted and treated with intravenous antibiotics only.This report is for an unk - construct: 3.5 mm reconstruction plate/screws.This is report 2 of 4 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown device/unknown lot.Part and lot numbers are unknown; udi number is unknown.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: UNK - CONSTRUCTS: 3.5 MM RECONSTRUCTION PLATE/SCREWS
• Type of Device: PLATE, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15379913
• MDR Text Key: 299473448
• Report Number: 8030965-2022-06538
• Device Sequence Number: 1
• Product Code: JEY
• 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
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2022
• 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
• Patient Outcome(s): Other