MAUDE Adverse Event Report: SYNTHES SELZACH UTN Ø8 L330 CPL W/END CAP SST; NAIL, FIXATION, BONE

Catalog Number 278.630

Device Problem Mechanical Jam (2983)

Patient Problem No Code Available (3191)

Event Date 09/30/2015

Event Type  Injury  

Manufacturer Narrative

Device became stuck intra-op and therefore was not implanted / explanted.(b)(6).(b)(4).Device is not distributed in the united states, but is similar to device marketed in the usa.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records has been requested.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 (b)(6) reports an event in france as follows: during implementation of the left tibia nailing surgery a nail reportedly broke.The surgeon was able to remove the nail due to total blocking of the nail fixing part with its ancillary and after the final lock and reamed intramedullary canal, thereafter the surgeon used a larger diameter nail (9).Upon receipt of the nail, it was found that the thread of the connecting screw is broken off and is stuck in the nail.The nail was found to be intact and was not broken.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device history record review: manufacturing location: (b)(4) - manufacturing date: february 13, 2015.No anomalies were detected during device history record review.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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: product investigation summary: the connecting screw was found broken at the outside thread.The first 10-15mm of the screw were broken and still jammed in the nail.Furthermore, marks and nicks were discovered at the knurled surface.There are marks of forcible and inadequate use at the head of the nail.A forceps or similar instrument was certainly used on the implant.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Because of the various signs of damage on the connecting screw, it is likely that the threaded part was not inserted/aligned correctly into the nail.Also, during the screwing portion of the procedure, there were likely high applied mechanical forces on the connecting screw which could cause the complained issue.The complaint relevant dimensions were checked, as far as possible, and found to be in compliance with specifications.The microscopic view of the broken surface does not show any anomalies, which indicates material conformity to the specifications.Based on the investigation results, the cause of failure is not due to any manufacturing non-conformances.No product fault could be detected.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.

• Brand Name: UTN Ø8 L330 CPL W/END CAP SST
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer (Section G): SYNTHES SELZACH; bohnackerweg 5; selzach CH254 5; SZ CH2545
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5204389
• MDR Text Key: 30495554
• Report Number: 3009417901-2015-10028
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2015

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 278.630
• Device Lot Number: 5932921
• Other Device ID Number: (01)07611819012370(10)5932921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2015
• Initial Date FDA Received: 11/05/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/24/2015; 12/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR