MAUDE Adverse Event Report: SYNTHES BETTLACH 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 38MM¿STERILE; APPLIANCE, FIXATION, NAIL

Catalog Number 413.338S

Device Problems Difficult to Remove (1528); Material Deformation (2976)

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 03/01/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(4).A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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

Synthes (b)(4) reported an event in (b)(6) as follows: it was reported that during a tomofix plate system explant surgery on (b)(6) 2016, a locking screw was difficult to remove and the extraction screw tip broke during attempted removal of this screw.The surgeon noted that the hexagonal head of the locking screw which has implanted in the second distal hole was worn out.When the surgeon attempted to remove this locking screw with the extraction screw, the extraction screw broke and the tip fragment remained in the locking screw head.The surgeon used carbide drills to drill the bone away from around the locking screw and was able to explant it.The surgery was completed with a 60 minute delay due to the reported event.The initial implant surgery was performed on (b)(6) 2014 as part of a high tibial osteotomy.This report is 2 of 2 for com-(b)(4).

Manufacturer Narrative

(b)(6).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.

• Brand Name: 5.0MM TI LOCKING HEAD SCREW SELF-TAPPING 38MM¿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: 5523731
• MDR Text Key: 41077954
• Report Number: 9612488-2016-10158
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK000682
• 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
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2023
• Device Catalogue Number: 413.338S
• Device Lot Number: 8570722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention