MAUDE Adverse Event Report: SYNTHES SELZACH INSERTION HANDLE FOR SUPRAPATELLAR; NAIL, FIXATION, BONE

Catalog Number 03.010.440

Device Problems Sticking (1597); Mechanical Jam (2983)

Patient Problems Bone Fracture(s) (1870); Sedation (2368)

Event Date 03/06/2015

Event Type  Injury  

Event Description

It was reported that the doctor successfully completed the implantation of a tibial nail for a distal 1/3 tibia fracture through a suprapatellar incision with use of the synthes suprapatellar tibial nail instrumentation.However, when trying to remove the insertion handle from the nail with the ball hex screwdriver, the connecting screw would not smoothly disengage from the nail.The driver required a significant amount of force to produce only a quarter turn of the screw.It got to a point where the connecting screw would not turn, so a ratchet wrench was used in conjunction with the ball hex driver.So much force was needed to produce any movement from the screw that by some mechanism an additional fracture (that was not present at the start of the case) was created around the proximal interlock screws at the proximal 1/3 of the tibia.The connecting screw was eventually removed with use of the ball hex driver.An additional proximal screw was placed through the nail by way of perfect circles and the case was completed.There was a sixty (60) minute delay to surgery.This report is 2 of 3 for (b)(4).

Manufacturer Narrative

Patient date of birth and weight are unknown.Device is an instrument and is not implanted or explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be 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

Product investigation summary: the complaint condition for the cannulated connecting screw for percutaneous instruments (03.010.404 / lot u197483) was likely caused by the device becoming cross-threaded with the inserted nail; however, this complaint is not a result of any design related deficiency.No product issue was identified in the complaint or noted upon examination of the returned insertion handle for suprapatellar (03.010.440 lot number 14-4021).The cannulated connecting screw for percutaneous instruments (03.010.404) and insertion handle for suprapatellar (03.010.440) are instruments routinely used in the suprapatellar instrumentation for titanium cannulated tibial nails system.The returned insertion handle for suprapatellar (03.010.440) was received in good condition consistent with a year of use.The device was manufactured in may 2014 and is one year old.The associated drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.No product issue was identified in the complaint description or noted upon examination.The condition of the returned device does not agree with the complaint description.Whether the complaint condition for this device can be replicated is not applicable for this condition.Device is 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

(b)(4): subject device has been received; no conclusions could be drawn as the device is entering the complaint system.(b)(4).No non-conformance reports were generated during production.Review of the device history record slowed 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.

• Brand Name: INSERTION HANDLE FOR SUPRAPATELLAR
• 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: 4610024
• MDR Text Key: 18639600
• Report Number: 2520274-2015-11895
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/06/2015

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: 03.010.440
• Device Lot Number: 14-4021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/06/2015
• Initial Date FDA Received: 03/17/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/26/2015; 05/08/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention