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

Catalog Number UNK - ELASTIC NAILS: TITANIUM

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

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown nail/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.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: müller m.C., et al (2013)elastic titanium nails for minimally invasive intramedullary splinting of metacarpal fractures, z orthop unfall volume 151, pages 525-531(germany) doi http://dx.Doi.Org/10.1055/s-0033-1350875.This study aims to analyze the results and complications after elastically stable intramedullary nailing of subcapital and shaft fractures of metacarpals 2-5.Within a period of 5 years (january 2006-december 2010),95 consecutive patients underwent intramedullary osteosynthesis with a titanium elastic nail (titanium elastic nail, ten, synthes, bochum, germany).In 42 men and 21 women (mean age 41 years, range 15-89 years), intramedullary osteosynthesis was performed a mean of 4.1 days (1-15 days) after the accident event.6.3 patients underwent clinical follow-up after a mean follow-up of 14.0 ± 5.2 weeks.The following complications were reported as follows: four patients had a subjectively irrelevant extension deficit of 5°, and no rotation errors were found.Fig.5 misalignment of the ten tip outside the head fragment.After repositioning of the ten, the fracture healed without problems.In 3 cases, skin irritation occurred at the nail entry site after the soft tissues had subsided, this was caused by a ten that was too long.Re-shortening was necessary in these cases.Two superficial wound infections healed under conservative therapy, and premature removal of the ten was not necessary.Fig.6 a to c telescopic effect after intramedullary splinting of long oblique shaft fractures without sufficient clamping of the ten in the shaft region of an (b)(6)-year-old female patient.The patient was not included in the study.This report is for an unknown synthes titanium elastic nail (ten).This is report 2 of 2 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 19380 ; 6103142063
• MDR Report Key: 11777241
• MDR Text Key: 249049431
• Report Number: 8030965-2021-03577
• 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,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2021

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: 04/09/2021
• Initial Date FDA Received: 05/05/2021
• 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