MAUDE Adverse Event Report: SYNTHES GMBH UNK - ELASTIC NAILS: TITANIUM; NAIL, FIXATION, BONE

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 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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: hettchen, m.Et al.(2016), elastic stable intramedullary nailing (esin) of metatarsal fractures, zeitschrift fur orthopadie und unfallchirurgie, vol.154, pages 148-156 (germany).The aim of this study is to utilize the principle of closed reduction and antegrade elastic intramedullary splinting, as described by metaizeau (prévot nail) for the treatment of fractures of the long bones in growing age and used by our clinic for stabilization of clavicle shaft fractures and subcapital and short shaft oblique and spiral fractures of the metacarpus.From january 2007 to december 2013, a total of 19 patients underwent elastic stable intramedullary nailing (esin) using titanium elastic nails (ten).There were 7 males and 12 females with a mean age at time of surgery: 41.8 years, range: 11-82 years.The mean follow-up was 25.6 ± 21.3 months (range: 3-72 months).The following complications were reported as follows: 1 case had soft tissue irritation occurred at the nail entry site due to the inserted ten after swelling of the foot had subsided, so that re-shortening was necessary.The wound as well as the fracture subsequently healed without problems.A (b)(6)-year-old female patient had fracture shortened on healing due to insufficient clamping of the ten in the shaft area caused by the treatment of a long, proximally extending oblique fracture of the 5th metatarsal.The aofas midfoot score was 87 at the follow-up examination 8 months after metal removal.This report is for an unknown synthes ten.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - ELASTIC NAILS: TITANIUM
• Type of Device: NAIL, FIXATION, BONE
• 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: 11784789
• MDR Text Key: 264503598
• Report Number: 8030965-2021-03636
• Device Sequence Number: 1
• Product Code: JDS
• 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: Physician
• Type of Report: Initial
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• 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: 04/12/2021
• 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