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

Catalog Number UNK - ELASTIC NAILS: TITANIUM

Device Problem Device Slipped (1584)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Without a valid lot number the device history records review could not be completed.This report is for one (1) unknown/unk - elastic nails: titanium/ part and lot numbers are unknown.Without the specific part and lot number, the udi is not available.Complainant device is not expected to be returned for manufacturer review/ investigation.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

Device report from synthes europe reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: xu h.W.,., et al (2015) ao elastic intramedullary nailing for the treatment of clavicle fractures, china j orthop trauma ,volume 28 , no.2 , pages 101-106, (china).This study aims to report the use of titanium elastic intramedullary nail (ten) to fix clavicle fracture using minimally invasive surgery, and satisfactory therapeutic effect was obtained.From february 2010 to february 2013,a total of 62 patients (27 males, 35 females) age ranged from 15 to 62 years, with a mean of 37.6 years with a fracture in the middle one-third of the clavicular shaft underwent ten (synthes, switzerland) fixation.55 patients received follow-up and were counted in the data statistics.The average follow-up time was 11.4 months for the 55 patients.He following complications were reported as follows: the fracture line of three patients was still clear at 10 months after the operation, and the computed tomography (ct) suggested that the fracture had not yet reached bony union, but the patients had no obvious pain, there was no local abnormal activity, and the range of motion of the shoulder joint was good.This was considered delayed fracture union.Local stabbing pain at the tail of the nail occurred in five patients.Five patients had tenderness at the end of the nail and formed local bursa, which were considered to be caused by the bent tail being retained for too long and improper management of the tail.The pain disappeared after removal of the internal fixation and resection of the bursa.1 case of poor result according to herscovici evaluation results for postoperative shoulder joint function where poor result is severe pain, inability to work, range of motion less than 45°, and grade 2 abduction muscle strength.3 cases of non-union.One of the 3 patients who had delayed fracture union was a (b)(6) year-old patient the fracture line was still clear at 10 months after the operation, and the computed tomography (ct) suggested that the fracture had not yet reached bony union, but the patients had no obvious pain, there was no local abnormal activity, and the range of motion of the shoulder joint was good.Considering the slow fracture union and partial separation from the periosteum at the fracture end, and at the same time, the fracture was a simple fracture with a small contact,t was caused by severe damage to the intramedullary blood supply after the intramedullary nail was inserted.Among the local stabbing pain at the tail of the nail occurred in five patient, partial withdrawal of the internal fixation from loosening occurred in one case, and the partially withdrawn intramedullary nail was cut off and immobilization was carried out.This report is for an unknown synthes ten.This report is for one (1) unk - elastic nails: titanium.This report is 3 of 3 for (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 wrights lane east; west chester, PA
• MDR Report Key: 11838218
• MDR Text Key: 263514889
• Report Number: 8030965-2021-03998
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - ELASTIC NAILS: TITANIUM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2021
• Initial Date FDA Received: 05/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention