MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: LC-DCP PLATE/SCREWS; PLATE, FIXATION, BONE

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

Patient Problems Wound Dehiscence (1154); Bone Fracture(s) (1870); Necrosis (1971); Nerve Damage (1979); Pain (1994)

Event Type  Injury  

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.There are multiple patients.All known information is provided in the literature article.510k: this report is for an unknown lc-dcp plate/screw construct/unknown lot.Part and lot number are unknown; udi number is unknown.There are multiple unknown dates of implantation between 2003 and 2018.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.

Event Description

This report is being filed after the review of the following journal article: innocenti, m.Et al.(2021), the role of vfg in wrist arthrodesis: long term results in a series of 11 patients and literature review, injury, vol.52, pages 3624-3634 (italy).This literature presents the authors' experience with a self- developed wrist fusion technique with vascularized fibula graft (vfg) practiced in 11 distal radius defects including the radiocarpal joint.Between 2003 and 2018, a total of 11 patients with distal radius defects underwent total wrist fusion (twf) with vfg.Implant used was a limited bone contact dynamic compression plate (lc-dcp) with variable thickness and screws dimension.Namely, a plate thicker in the forearm with screws 3.5 and thinner at the capometacarpal level with screws 2.7.Fibula fusion was seen in all the patients, after a mean time of 4,7 months (range 3¿7 months).The following complications were reported: 1 case of ulnar impingement with painful prono-supination, then treated with caput ulnae resection (darrach procedure).2 wounds dehiscence, with one of them resulting in exposure and partial necrosis of the previous fibula flap (thus requiring a second osteo-cutaneous fibula free flap).1 stress fracture at the fibula-radius interface after plate removal for extensors tenosynovitis with the need of a new bone fixation.This report is for an unknown synthes lc-dcp.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: LC-DCP PLATE/SCREWS
• Type of Device: PLATE, FIXATION, 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: 15311812
• MDR Text Key: 298798424
• Report Number: 8030965-2022-06080
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• 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): Required Intervention