MAUDE Adverse Event Report: SYNTHES BETTLACH 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 40MM; APPLIANCE,FIXATION,NAIL

Catalog Number 413.340S

Device Problem Fitting Problem (2183)

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

Event Date 03/22/2016

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).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 was conducted.The report indicates that the: manufacturing site: (b)(4), manufacturing date: 17.Sep.2014, expiry date: 01.Sep.2014, 413.340s ¿ 9136357.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

It was reported that during the extraction of the reported plate on (b)(6) 2016, the surgeon experienced difficulty removing the proximal lateral screw out of the plate in question.Eventually, he turned around both the plate and screw together in order to remove them out of the patient's body.There was a 20-minutes surgical delay.This complaint involves 1 part.This report is 1 of 1 for com- (b)(4).

Manufacturer Narrative

A product investigation was completed: the returned devices were received, as reported in the complaint description, the locking screw blocked in the plate.The inner, distal surface of the returned plate fragment is damaged in the region between a combi-hole and the crack.The recess of the self tapping locking screw is deformed.In the attempt of remove the screw from the plate it could be measured that the removal torque necessary was over 10.32nm, more than 2.5 times higher as the recommended tightening torque.The screw could not been removed from the plate due to the recess deformation occurred during the removing attempt.Based on the provided information it is impossible to determine the exact cause for this occurrence, but it is likely that the incorrect or no torque limiter was used during insertion of the screw and/or the time period of the inserted screw and plate may have played a main role of this occurrence.However, it could not been determined that the returned complaint is due to misuse or wrong application and user error.No product fault could be detected.Event date of (b)(6) 2016 and unknown inadvertently reported on initial medwatch event date of (b)(6) 2016 is correct.(b)(4).Expiration date in reported dhr on initial medwatch should have been (b)(6) 2024.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: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 40MM
• Type of Device: APPLIANCE,FIXATION,NAIL
• 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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5653327
• MDR Text Key: 45142469
• Report Number: 9612488-2016-10234
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK023941
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2016

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: 413.340S
• Device Lot Number: 9136357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2016
• Initial Date FDA Received: 05/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 58 YR