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

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

Patient Problems Bone Fracture(s) (1870); Hematoma (1884); Nerve Damage (1979); Loss of Range of Motion (2032); Post Operative Wound Infection (2446); Paresthesia (4421); Unspecified Tissue Injury (4559)

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: cintean, r.Et.Al.(2022).Radial vs.Dorsal approach for elastic stable internal nailing in pediatric radius fractures¿a 10 year review., journal of clinical medicine, vol.11 (4478) pages 1-10., (germany).The aim of this retrospective exploratory review was to investigate and compare the advantages and disadvantages of both approaches to the distal radius using esin (elastic stable intramedullary nailing).Between january 2010 and december 2019, a total of 237 patients with mean age 8.3 _ 3.4 (1¿16) years treated with open or closed reduction and internal fixation with at least one radial intramedullary nail.In 201 cases (82%), they performed a dorsal approach; 44 fractures (17.9%) were treated with a radial approach.In total, they found 25 (10%) surgery-related complications, of which 21 (8.6%) needed further surgical treatment.The median clinical follow-up period was 4.7 _ 4.2 months (range 1.7¿28.1 months).The following complications were reported as follows: a total of 16 (7.9% of dorsal approaches) ruptures of the extensor pollicis longus tendon were observed and required operative treatment, one child showed an entrapment of the epl tendon and did not need further treatment after surgical release.In one case, an epl rupture due to adhesion to the callus formation was observed.One child with epl rupture was lost during follow-up.4 (9.1% of radial approaches) cases had hypesthesia of the thumb due to lesion of the superficial branch of the radial nerve (srnb) after esin.After early implant removal and cast immobilization after 1.1 months, one child complained about a persistent mild sensibility disorder which was addressed with physiotherapy.The palsy was consistent after a follow-up of 6 months after esin removal.No further surgical treatment was required.Two (0.8%) refractures occurred due to new adequate trauma at 1.1 and 1.6 months after implant removal.In one case, they decided to perform open reduction and plate osteosynthesis.In one case, a secondary loss of reduction 21 days after esin implantation was observed which required early implant removal, open reduction, and plate fixation.Two superficial wound infections were observed and required surgical treatment.One child with a diaphyseal forearm fracture showed limited range of motion (rom) in supination of >20_ after radial and ulnar esin implantation.After hardware removal, the rom improved to almost normal.Postoperative hematoma.Lesions of ulnar and median nerve.This report involves one unk - elastic nails: titanium.This is report 1 of 1 for (b)(4).

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: this report is for an unknown elastic nails: titanium/unknown lot.Part and lot numbers are unknown; udi 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 involves one unk - constructs: titanium elastic nail.

• Brand Name: UNK - CONSTRUCTS: TITANIUM ELASTIC NAIL
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 16264199
• MDR Text Key: 308377388
• Report Number: 8030965-2023-01122
• Device Sequence Number: 1
• Product Code: HTY
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• 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: 02/27/2023
• 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