MAUDE Adverse Event Report: SYNTHES BETTLACH NAVIGABLE AWL-TAP 5.0MM DUAL CORE/6MM HXC; NEUROLOGICAL STEREOTAXIC INSTR

Catalog Number 03.632.222

Device Problems Fitting Problem (2183); Device Operates Differently Than Expected (2913)

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

Event Date 02/03/2016

Event Type  malfunction  

Manufacturer Narrative

Patient initials are (b)(6).(b)(4).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)(6) - manufacturing date: january 28, 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.

Event Description

It was reported that a surgeon was using a navigable pedicle preparation 5mm tap and adapter to prepare for pedicle screw insertion during a surgical procedure on (b)(6) 2016.The tap became fixed in the adaptor and would no longer rotate, preventing the surgeon from using the ratchet ability to create the tap for the pedicle screw.No additional 5mm taps were available in the set, so the surgeon completed the procedure with another company's instrument.The procedure was successfully completed with no harm or adverse event to the patient.A surgical delay of five (5) minutes was reported.The surgeon had previously completed two (2) tapping procedures with these devices without malfunction.This report is 1 of 2 for com-(b)(4).

Manufacturer Narrative

: a product investigation was completed: a 5.0mm navigable awl-tap 6.0mm duel core (03.632.222) and a mating 12mm universal navigation interface (03.632.395) was returned.The instruments were examined and were found to assemble and operate as intended.As the complaint condition was unable to be replicated the complaint is unconfirmed.The reported failure mode is typically associated with wear and tear and/or inadequate cleaning/lubrication.This failure mode of a stuck awl-tap/interface construct is typically associated with the awl-tap/interface construct binding; therefore drawings related to both instruments were reviewed.Additionally the tolerance analysis for the proximal end of the instrument was reviewed.The documents were found to be satisfactory to describe the proper fit of the devices.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.The returned awl-tap was examined and a wear on the distal end of the 7mm diameter was noted.Additional witness marks were noted on the ball detents and on the 6mm hex coupling.The complaint condition was unable to be replicated as the devices were found to interact as designed.A device history review was performed for the awl-tap (03.632.222) and the navigation interface (03.632.395) lot numbers and in each instance no material review reports, non-conformance reports or complaint-related issues were identified with the lots 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: NAVIGABLE AWL-TAP 5.0MM DUAL CORE/6MM HXC
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTR
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5469649
• MDR Text Key: 39317621
• Report Number: 9612488-2016-10110
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK122211
• 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: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.632.222
• Device Lot Number: 9035688
• Other Device ID Number: (01)10705034719566(10)9035688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2015
• 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: 62 YR
• Patient Weight: 75