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 Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - 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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and 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 taiwan as follows: this report is being filed after the review of the following journal article: wang, y.C.Et al.(2015), titanium elastic nail versus plate fixation of displaced midshaft clavicle fractures: a retrospective comparison study, kaohsiung journal of medical sciences, vol.31, pages 473-479 (taiwan).This study has two purposes: (1) to compare the clinical results between the titanium elastic nail (ten) and plate fixation of the displaced midshaft clavicle fracture; and (2) to demonstrate the relationship between length shortening and functional outcome after ten fixations, especially in the comminuted fracture pattern.From november 2006 to august 2009, a total of 25 patients were treated with the titanium elastic nail (ten) system (synthes holding ag, west chester, pa, usa).The mean age of the patients was 37.5 years (range 16e66 years) and these patients were followed up for at least 12 months.The following complications were reported: 5 patients had implant migration.5 patients had a foreword proximal nail insertion site causing skin irritation.2 patients had skin numbness.This report is for an unknown synthes ten.This report is for (1) unk - elastic nails: titanium.This report is 3 of 3 (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: 11747361
• MDR Text Key: 264141273
• Report Number: 8030965-2021-03426
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• 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: 04/29/2021
• 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
• 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