MAUDE Adverse Event Report: SYNTHES SELZACH AIMING ARM FOR SUPRAPATELLAR; NAIL, FIXATION, BONE

Model Number 03.010.441

Device Problem Failure to Align (2522)

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

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Manufacturing location: (b)(4).Supplier: (b)(6).Manufacturing date: feb 22, 2011.No ncrs 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 device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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

It was reported that during a nailing of a tibial shaft while drilling through the guide the drill tip was not going through the locking holes of the nail and was hitting the nail directly.The nail was pulled out to make sure everything aligned properly.It appeared to line up properly and was placed back in the patient but the drill bit was still hitting the nail.The surgeon decided to apply pressure to the aiming arm and move it around, at that point the drill bit was able to go through the locking holes.This caused a 5-10 minute surgical delay.There was no report of patient harm and surgery was completed successfully.Concomitant devices reported: connecting screw (part # 03.010.404, lot # u205159, quantity 1),nail (part # 04.004.446s, lot# unknown, quantity 1), drill bit (part# unknown, lot # unknown, quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: a product investigation was completed: this complaint was unable to be confirmed as the mating implants and instrumentation used in the surgery were not returned to assemble the actual construct used in this surgery.This complaint was unable to be replicated as the mating implants and instrumentation used in the surgery were not returned.The concomitant connecting screw (part 03.010.404, lot u203159) was returned without an allegation against it.Minor wear marks consistent with use exist on the distal shaft area just proximal to the distal thread form.However, there is no evidence that this concomitant device contributed to or caused this complaint.No new malfunctions were identified as a result of the investigation.A visual inspection under 5x magnification, device history record (dhr) review and drawing review were performed for the returned complaint device as part of this investigation.No product design issues or discrepancies were observed.The returned aiming arm for suprapatellar is a reusable instrument in the suprapatellar instrumentation for titanium cannulated tibial nails system which is part of the expert nailing system with radiolucent instrumentation.Instructions for use can be found in technique guide.Device shows no damage, wear or abnormalities.A functional test could not be performed as the mating implants and instrumentation used in the surgery were not returned to assemble the actual construct used in this surgery.The relevant drawings were reviewed during this investigation.No product design issues or discrepancies were observed.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: AIMING ARM 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6736824
• MDR Text Key: 80883770
• Report Number: 3000270450-2017-10249
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982068835
• UDI-Public: (01)10886982068835(10)10-6493
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111667
• 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: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.010.441
• Device Catalogue Number: 03.010.441
• Device Lot Number: 10-6493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2011
• 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