MAUDE Adverse Event Report: SYNTHES SELZACH 8MM TI CANN TIBIAL NAIL-EX W/PROX BEND 330MM-STERILE; NAIL, FIXATION, BONE

Catalog Number 04.034.246S

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem Sedation (2368)

Event Date 12/11/2014

Event Type  Injury  

Event Description

Device report from (b)(6) reports the following: in the removal operation of expert tibial nail, the extraction screw in question did not connect to the nail.Eventually, the nail and the extraction screw were successfully connected and the screw was taken out after many attempts.The patient is now well on the way to recovery without harm.The operation was delayed by 60 minutes due to this event.This is report 1 of 3 for complaint (b)(4).

Manufacturer Narrative

Device used for treatment, not diagnosis.Implant date: unknown.No nonconformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 8MM TI CANN TIBIAL NAIL-EX W/PROX BEND 330MM-STERILE
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH25 45; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH25 45; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4413137
• MDR Text Key: 17263201
• Report Number: 3000270450-2015-10007
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK040762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Catalogue Number: 04.034.246S
• Device Lot Number: 3189453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2009
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention