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

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Pain (1994); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 11/08/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in germany as follows: this report is being filed after the review of the following journal article: schmitt s, et al.(2023), dynamic palmar dislocation of the ulnar head at the distal radioulnar joint (druj) after radius shaft malunion, archives of orthopaedic and trauma surgery 143:2781¿2787, https://doi.Org/10.1007/s00402-022-04684-y (germany).This study hypothesized that the dynamic palmar dislocation of the ulnar head at the distal radioulnar joint is a result of malunion of the radius at the shaft level.It supported the thesis that simple radius corrective osteotomy at the site of malunion is sufficient to restore the stability of the distal radioulnar joint.Between 2007 and 2014, 10 patients with palmar dynamic dislocation of the ulnar head at the distal radioulnar joint.Underwent a single radius corrective osteotomy.6 patients (5 women and 1 man) with a mean age of 34.1 [min¿max 25¿45] years could be followed up after a mean time of 5.6 [min¿max 0.5¿6] years.A palmar approach to the radius was used for all patients.The plate (unknown synthes small fragment limited contact dynamic compression plate system (lc-dcp) was fixed at the proximal side of the malunion without bending.A straight osteotomy was performed at the apex of the deformity.After plate fixation with adequate compression at the volar side, a dorsal open wedge osteotomy was created.The postoperative management entailed an immobilization in a palmar forearm cast for 4 weeks.Thereafter, physiotherapy was initiated.Complications were reported as follows: 1 patient developed a palmar subluxation of the distal radius in an ulna-plus situation that was treated with a secondary ulnar shortening osteotomy 12 months following the radius correction osteotomy.Further healing was uneventful.1 patient had insufficient osteosynthesis which led to early failure of the plate osteosynthesis.Revision of the osteosynthesis using another plating system had to be performed 1 month following the original radius correction osteotomy.Further healing was uneventful.Patients reported a mean pain on exertion of vas 4.7 (min¿max: 1¿8).This report is for the unknown synthes small fragment limited contact dynamic compression plate system (lc-dcp).This is report 1 of 1 for complaint (b)(4).A copy of the clinical evaluation form is being submitted with this regulatory report.

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.D1, d2, d3, d4, g4-510k: this report is for an unknown constructs: lc-dcp plate/screws/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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: LC-DCP PLATE/SCREWS
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• 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: 18666971
• MDR Text Key: 334844070
• Report Number: 8030965-2024-02137
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• 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