MAUDE Adverse Event Report: SYNTHES GMBH UNK - ELASTIC NAILS: TITANIUM; PIN, FIXATION, SMOOTH

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

Patient Problem Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown titanium elastic nail/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.

Event Description

This report is being filed after the review of the following journal article: salonen, a., salonen, h., and pajulo, o.(2012), a critical analysis of postoperative complications of antebrachium ten-nailing in 35 children, scandinavian journal of surgery, vol.101 (xx), pages 216¿221 (finland).The aim of this retrospective study is to review and critically analyze the results of a cohort of finnish children treated with ten-nailing for dislocated antebrachium and find possible risk factors leading to complications.Between january 2001 to december 2005, a total of 35 patients (20 male and 15 female) with a mean age of 12.3 years (ranged from 5.2 to 17.4 years) were included in the study.Surgery was performed using the titanium elastic nail (ten synthes paoli, pa, usa).Patients with post-operative problems were followed up from 31 to 74 months, with a median of 54 months.The following complications were reported as follows: 5 patients had short-term problems during the follow up time.7 had long-term problems during the follow up time.3 out of 7 patients with long-term complications had pain caused by ulnar ten-nail.4 patients complained of ulnar nail discomfort at follow-up visits.11 patients had minor postoperative complications.Patient 1, a male patient had several complications, he was found to have median nerve neuropraxia already before operation and the neural symptoms were deteriorated postoperatively.At consequent follow up the symptoms persisted, and the patient developed 20-degree supination deficit and finally a re-fracture resulted from a fall before removal of ten-nails.Patient 2 had ulnar nail end causing discomfort at 5 weeks follow-up.Patient 3 had supination deficit.In patient 4, the ulna was fixed with a ten-nail and the radius was fixed dorsally with a single kirschner-wire.Before the operation a partial ulnar nerve deficit was noted and postoperatively the ongoing pain over the ulnar nerve distribution was reported by the patient.In the first control visit the flexor contracture was noted, which led to a referral to the hand surgeons and a volkmann¿s ischemic contracture was diagnosed.Consequently, the osteosynthesis material was removed by the hand surgeons concurrently with a flexor release operation ten weeks after the primary operation.During the follow up time the patient recovered fully.In patient 5, the fracture was still unstable after the operation.The short-arm cast of the patient was changed to a long arm cast in the first post-operative day and finally the patient recovered without any additional problems.Patient 6 had ulnar nail end causing discomfort.In patient 7, 12-degree volar angulation and protruding ulnar nail were noted five weeks after operation.The nail was removed, and the patient wore a daytime short arm cast afterwards.Patient 8 had ulnar nail causing discomfort or pain.The patient also suffered from wound infection after removal of ten-nail and was treated by oral antibiotics.Patient 9 suffered from post-operative paraesthesia over the dorsum of the thumb (radial nerve deficit).However, this disappeared before second control and the patient recovered fully.Patient 10 had the ulnar ten-nail malposition recognised on next day after the operation.However, the fracture united well without surgical intervention.In patient 11, the re-fracture was treated by plating both the radius and the ulna.In patient 12, the re-fracture occurred after first control following heavy tackling in football and the patient was operated on with new ten-nails and casting.This report is for an unknown synthes titanium elastic nail.It captures the reported patient 10 who had the ulnar ten-nail malposition recognized on next day after the operation.However, the fracture united well without surgical intervention.This is report 7 of 10 for (b)(4).Additional devices reported under related complaint (b)(4).

• Brand Name: UNK - ELASTIC NAILS: TITANIUM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11761111
• MDR Text Key: 264342832
• Report Number: 8030965-2021-03492
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• 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: 04/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1