MAUDE Adverse Event Report: SYNTHES BETTLACH 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 32MM¿STERILE; APPLIANCE,FIXATION,NAIL

Catalog Number 413.332S

Device Problems Peeled/Delaminated (1454); Dull, Blunt (2407)

Patient Problem Sedation (2368)

Event Date 10/16/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is expected to be returned for manufacturer review/investigation, but has yet to be received.Subject device has not been received.Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Report from synthes europe reports an event in (b)(6) as follows: it was reported that a removal surgery took place after hto with a reported tomofix plate on (b)(6) 2015.During the surgery, the surgeon had difficulty in removing the reported screws inserted at the most distal end part of the plate detailed as following; the surgeon was able to put tip of the screwdriver on the reported screw to turn the screw during the removal surgery.However, turning the screw was not smoothly performed.As a result, the screw head became dull after repeated turning.The surgeon used a hollow reamer to shave around the stuck screw.Then, the surgeon successfully removed the reported screw, eventually.The surgery was delayed for 30 minutes.No patient harm was reported.This report is 2 of 3 for (b)(4).

Manufacturer Narrative

Device history records was conducted.The report indicates that unknown which of the following screws were affected: 413.370s/ lot number 9013713, manufacturing location: (b)(4), manufacturing date: 18.June 2014, expiry date: 01.June 2024.No anomalies were detected during device history record review.No ncrs 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.413.360s/ lot number 8928865, manufacturing location: (b)(4), manufacturing date: 23.April 2014, expiry date: 01.April 2024, no anomalies were detected during device history record review.No ncrs 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.413.355s/ lot number 8943594, manufacturing location: (b)(4), manufacturing date: 05.May 2014, expiry date: 01.April 2024.No anomalies were detected during device history record review.No ncrs 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.413.332s/ lot number 9064936, manufacturing location: (b)(4), manufacturing date: 23.July 2014, expiry date: 01.July 2024, no anomalies were detected during device history record review.No ncrs 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 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

(b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Consumer inadvertently checked on initial medwatch; should have been health professional.Part 413.332s, lot number 9064936: manufacturing location: (b)(4).Manufacturing date: 23july2014.Expiry date: 01july2024.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 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

Device was used for treatment, not diagnosis.(b)(4).A manufacturing investigation was performed for the subject device (5.0mm ti spacer 2m, part number 413.309s, lot number 9064936).The subject device screw was received with the head cut off from the screw shaft and packaged in a different package from the original packaging.The screw shaft shows strong usage marks.Based on the measurements, a production failure can be excluded.The complaint condition is confirmed but is not valid from a manufacturing standpoint.No manufacturing related issues were identified and/or confirmed.A root cause could not be determined.Possible reasons for the complaint condition could have been that a damaged screwdriver was used and/or soft tissue ingrowth in between plate thread and screw head thread and an overloading situation lead to the breakage of the screws.It is recommended that only intact instruments for surgeries in general be used and procedures be performed according to the surgical technique guide.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A manufacturing investigation was performed for the subject device (5.0mm ti locking head screw self-tapping 32mm¿sterile).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 32MM¿STERILE
• 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5196174
• MDR Text Key: 30202614
• Report Number: 2520274-2015-17004
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK000682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 413.332S
• Device Lot Number: 9064936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention