MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: 3.5/4.5 MM LCP METAPHYSEAL PLATE; PLATE, FIXATION, BONE

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

Patient Problems Pain (1994); Skin Discoloration (2074); Muscle/Tendon Damage (4532)

Event Date 10/21/2022

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.Additional narrative: 510k: this report is for an unknown 3.5/4.5mm lcp metaphyseal plate.Device available for evaluation: 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

Device report from synthes reports an event in united kingdom as follows: this report is being filed after the review of the following journal article: roberts t., kocialcowski c., and cowey a.(2022), dorsal bridging plates for the treatment of high and low energy distal radius fractures, journal of clinical orthopaedics and trauma, vol.35 (102048), pages 1-5 (united kingdom).The aim of this study was to assess the functional outcomes, radiographic analysis and complications of a case series of patients treated with dorsal bridging plate.Between 2018 and 2020, a total of 26 distal radius fractures in 25 patients (4 male and 21 female [one bilateral]) with a mean age of 66 years (range 39-85) were included in the study.Plate fixation was to either the index or middle metacarpal as per surgeon preference, with proximal fixation to the radius.The plate used was the depuy synthes (warsaw, usa) 3.5 mm 10, or 12 hole lcp metaphyseal plate.Fixation was with locking screws to create an ¿internal¿ external fixator construct.Plates were removed after a mean of 95 days (45-200).The mean follow-up period was unknown.The following complications were reported as follows: 4 patients developed complications: 1 patient sustained an extensor policis longus (epl) tendon rupture, which was repaired at the time of dbp removal while 3 patients developed complex regional pain syndrome (crps).This was diagnosed clinically by consultant hand surgeons in the hand clinic and included symptoms of continued pain and stiffness, altered skin colouration, shiny appearance to skin and abnormal hair distribution.All crps diagnoses occurred in women between the ages of 40 and 64 years and in patients who underwent primary fixation with a dbp.All cases were treated with urgent hand physiotherapy with resolution in two patients and ongoing symptoms in one patient.This report is for an unknown synthes 3.5 mm lcp metaphyseal plate/screws.This is report 2 of 2 for complaint: (b)(4).A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - PLATES: 3.5/4.5 MM LCP METAPHYSEAL PLATE
• 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: 16078345
• MDR Text Key: 306437371
• Report Number: 8030965-2022-11700
• Device Sequence Number: 1
• Product Code: HWC
• 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: 12/30/2022
• 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: 12/07/2022
• 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