MAUDE Adverse Event Report: SYNTHES GRENCHEN 3.5MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 14MM; APPLIANCE,FIXATION,NAIL

Catalog Number 412.103S

Device Problem Fitting Problem (2183)

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

Event Date 05/17/2017

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient information not available for reporting.(b)(4).Device malfunctioned intra-operatively and was not implanted / explanted.(b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: manufacturing location: (b)(6).Manufacturing date: feb 01, 2017 expiry date: jan 01, 2027.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.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 on an event in (b)(6) as follows: it was reported that the locking screw was used in surgery for the distal tibial fracture on (b)(6) 2017.The lcp distal tibia bend plate was used during the procedure.When the plate was finally being fixed with the locking screw in question by the torque limiting attachment, the surgeon could not fix the screw in question because the screw was spinning around.When the surgeon tried again, the same problem occurred.The surgeon removed the locking screw in question and closed the wound.The surgery was extended for 5 minutes.No adverse consequence to the patient was reported.This complaint involves 1 part.Concomitant parts: lcp distal tibia bent plate (part# unknown / lot# unknown / quantity 1).1x torque limiter, 1.2 nm, 03.110.002/ lot 1003099.1x handle for torque limiters, 03.110.005/ 9707623.1x screwdriver shaft stardrive, 314.453/ 9853859.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

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

A product investigation was performed.One locking screw stardrive®, self-tapping, was returned for investigation.The visual inspection has shown that the screw in question presents heavy wear marks on the thread of the screw head; the thread flanks are almost flat.The review of the device history records revealed that this part was manufactured in february 2017 according to the specifications.All parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.No manufacturing related issues that would have contributed to this complaint were found.No definitive root cause was able to be determined; however this complaint condition is most likely a result of the screw not being positioned appropriately so that the thread at the screw head got damaged during the insertion.Because of the damage, the complaint relevant dimensions cannot be checked for dimensional accuracy.The parts (1x 03.110.002/ lot 1003099, 1x 03.110.005/ 9707623, 1x 314.453/ 9853859) were returned as concomitant devices without an alleged complaint condition.Upon visual inspection, there is no evidence that these devices contributed to the complaint condition, and therefore no additional investigation will be performed.Although the exact cause cannot be determined, this complaint condition is likely a result of method of use, the complaint is determined not to be a result of a detected product related deficiency.No product related issues identified.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.

Manufacturer Narrative

(investigation summary): the following devices torque limiter (part #03.110.002, lot # 1003099, quantity 1), handle of torque limiter (part # 03.110.005, lot # 9707623, quantity 1) and screwdriver shaft stardrive (part #314.453, lot # 9853859, quantity 1) were reported on initial and follow-up medwatch reports as concomitant by error.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: 3.5MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 14MM
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CH254 0; SZ CH2540
• Manufacturer (Section G): SYNTHES GRENCHEN; solothurnstrasse 186; grenchen CH254 0; SZ CH2540
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6633649
• MDR Text Key: 77396342
• Report Number: 3009450884-2017-10083
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000684
• 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,Followup
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 412.103S
• Device Lot Number: L285924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1