MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: LCP DISTAL ULNA; PLATE,FIXATION,BONE

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

Patient Problems Pain (1994); Non-union Bone Fracture (2369); Numbness (2415); Skin Inflammation/ Irritation (4545)

Event Date 09/01/2021

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: im j.H., lee j.Y., kang h.V.(2021), the combined procedure of ulnar metaphyseal shortening osteotomy with triangular fibrocartilage complex foveal knotless repair, the journal of hand surgery, vol.46 (9), pages 822.E1-822.E7 (korea, south).The aim of this study is to present the authors' combined procedure that includes ulnar-shortening osteotomy (uso) at the ulnar metaphysis using an lcp distal ulnar plate (synthes, oberdorf, switzerland) and open triangular fibrocartilage complex (tfcc) foveal knotless repair using a pushlock anchor (arthrex, naples, fl) simultaneously through a single incision.A parallel saw blade (synthes) was used to facilitate osteotomy and the torn rul and the uclc are sutured using a competitor device.The following complications were reported as follows: an unknown number of patients complained of a tingling sensation or numbness resulting from excessive retraction at the area of the dorsal cutaneous branch of the ulnar nerve (dcbun) after surgery.All patients recovered completely after a few weeks without any treatment.An unknown number of patients complained about hardware irritation and removal of hardware was performed at a mean of 7.1 months after surgery.Most of the patients who complained about the irritation had aggravated pain on wrist supination.We considered that the dorsal hook of the plate might irritate the ecu during supination, and thus, we cut the dorsal hook of the plate before final fixation starting in 2015.After this modification, no patient has complained of hardware irritation.3 patients who started the daily and strenuous activities early without complete union showed delayed union.In an unknown number of patients, because of the difference of bone contour and the precontoured plate of the distal ulnar hook plate, difficulty in fixing the plate completely was encountered after osteotomy.The surgeon cut both hooks of the plate in those cases and achieved a tight fit and stability of osteotomy site without both plate hooks.2 patients had nonunion.This report is for an unknown synthes lcp distal ulna plate and unknown synthes locking screws.A copy of the literature article is being submitted with this medwatch.

• Brand Name: UNK - PLATES: LCP DISTAL ULNA
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13829370
• MDR Text Key: 287556491
• Report Number: 8030965-2022-01748
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• 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: 03/20/2022
• 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: 02/18/2022
• 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