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

Catalog Number 03.010.440

Device Problem Failure to Align (2522)

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

Event Date 05/19/2016

Event Type  malfunction  

Manufacturer Narrative

Patient initials are (b)(6).Patient weight is unknown.Implant and explant dates: device is an instrument and is not implanted or explanted.Subject device has been received; no conclusions could be drawn as the device is entering the complaint system.Device history record review: manufacturing location: (b)(4) - manufacturing date: september 5, 2011.No non-conformance 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.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.

Event Description

It was reported that a drill bit collided with the nail during a suprapatellar tibial nailing procedure on (b)(6) 2016.While the surgeon was drilling through the proximal aiming arm for the proximal interlocking screw, the drill bit hit the nail.It was noted that the aiming arm, connecting screw, and insertion handle were misaligned, which led to the reported event.The connecting screw was tightened down, after hammering, in order to seat the nail.In order to complete the procedure, the surgeon employed the perfect circle technique, which is often used for distal locking screw insertion and calls for drilling without an aiming arm.There was no additional medical intervention required.The procedure was completed successfully with a four (4) minute delay.Concomitant devices reported: a titanium cannulated tibial nail (part: 04.004.349s, lot: unknown, quantity 1) and a drill bit (part: 03.010.060, lot: unknown, quantity: 1).This report is 1 of 2 for (b)(4).

Manufacturer Narrative

A product investigation was completed: the returned instruments were reconstructed together in an attempt to create the complaint condition, but the complaint condition could not be recreated.Alignment of the aiming arm with the insertion handle and connecting screw was achieved when attempting to recreate the complaint condition, but during the subject procedure other variables could have contributed to the drill bit not going into the nail.Since only the aiming arm, insertion handle, cannulated connecting screw were returned, it is not possible to determine if the other parts which interacted with both devices during the complaint contributed to the drill bit colliding with the nail.Additionally, other factors such as the patient¿s condition and physical attributes could have impacted the positioning of the instrumentation used to facilitate locking and contributed to the complaint condition.Due to the tight tolerances and design, the construct(s) is susceptible to lateral forces during the surgery that are unable to be replicated.It is likely that soft tissue distractions forces contributed to this complaint condition.All parts received were in good condition with some minor wear and tear on the devices.A device history record review, a drawing review and occurrence rate review was done as a part of this investigation.Per the technique guide, the returned instrument(s) are part of the depuy synthes titanium cannulated tibial ¿ex nails when a suprapatellar approach is desired.Relevant drawings for the returned instruments were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.A device history review was performed for the returned instruments¿ lot numbers and in each instance no material review reports, non-conformance reports or complaint-related issues were identified with the lot numbers which may have contributed to the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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: INSERTION HANDLE FOR SUPRAPATELLAR
• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5704218
• MDR Text Key: 46761897
• Report Number: 3000270450-2016-10131
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2016

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 Catalogue Number: 03.010.440
• Device Lot Number: 11-3169
• Other Device ID Number: (01)10886982068828(10)11-3169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2016
• Initial Date FDA Received: 06/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2011
• 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 Age: 53 YR