MAUDE Adverse Event Report: SYNTHES SELZACH 10MM TI CANNULATED TIBIAL NAIL-EX/375MM-STERILE; NAIL, FIXATION, BONE

Catalog Number 04.004.455S

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2015

Event Type  malfunction  

Event Description

It was reported that a surgeon experienced difficulty removing a connecting screw from a tibial nail at the completion of an operation to set a broken tibia.The screw was inside of the insertion handle while it was being removed from the nail.An ¿unreasonable amount of force¿ was required to remove the screw.The procedure was completed successfully with no patient harm reported.A surgical delay of five (5) minutes was noted.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Device was not explanted.The investigation could not be completed; no conclusion could be drawn as no product was received.A review of the device history records has been requested.Device 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.

Manufacturer Narrative

Additional narrative: a device history review was conducted.The report indicates that only the sterilization and packaging was made at synthes (b)(4).As this complaint is not related to sterilization and packaging no dhr review from synthes (b)(4) is needed.Indicated manufacturing date is the date of the sterilization.Part was manufactured at monument, therefore this task will be re-assigned to monument for review of the manufacturing documents of part 04.004.455 lot 7286140.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.

• Brand Name: 10MM TI CANNULATED TIBIAL NAIL-EX/375MM-STERILE
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach PA 19380 CH2; SZ 19380 CH25
• 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: 4596008
• MDR Text Key: 5629393
• Report Number: 2520274-2015-11775
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK040762
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: 04.004.455S
• Device Lot Number: 7286140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2015
• Initial Date FDA Received: 03/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26 YR