MAUDE Adverse Event Report: SYNTHES BETTLACH CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS; EXTRACTOR

Catalog Number 309.530

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problems Sedation (2368); Device Embedded In Tissue or Plaque (3165)

Event Date 11/18/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient age, dob & weight not provided by reporter.Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Device history records was conducted.The report indicates that the: manufacturing location: (b)(4), part 309.530 / lot 9375810, art 309.530 / lot 9375810, manufacturing date: 20th march 2015, 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

Report from synthes (b)(4) reports an event in (b)(6) as follows:t it was reported that the removal surgery of tomofix plate (440.843s) was held on (b)(6) 2015 (the initial surgery was the closing wedge high tibial osteotomy.The date is unknown).Due to the problem of extracting the locking screws, the surgery was completed with metal debris being left inside the patient's body.The details are as follows: during the surgery, it was found that locking screws in the c- and d-holes of the tomofix plate had been fixed firmly.Therefore, the surgeon tried to remove the both locking screws with extraction screws.However, the shafts of both extraction screws were broken during the attempt.The surgeon decided to temporarily halt the extraction of the locking screws with the remaining extraction screws still left into them to continue extracting other locking screws.To remove the locking screws, the surgeon drilled into the remaining screw heads with the reported carbide drills.However, the thickness of the plate and broken screws obstructed the extraction, and it took 3 and half hours to remove them successfully.After approximately three and half hours later the tomofix plate and all screws were successfully removed by breaking down the remaining extraction screws and head of the locking screws with the reported carbide drills.However, by this point metal debris generated by drilling had spread into the patient's muscle fibers.The surgeon removed as much the debris as he could see, yet the x-ray photo taken after the surgery indicated that lot of the debris were still left inside the body.The patient has been stable so far.The surgeon commented that if the residual metal debris would not cause problems, the future treatment would not be required.This report is 2 of 2 for (b)(4).

Manufacturer Narrative

(b)(6).Product investigation summary: the following devices were received for evaluation: two (2) broken extraction screws (part 309.530), three (3) carbide drill-bits (parts 309.004s and 309.006s), one (1) tomofix plate (part 440.843s), two (2) damaged, unknown locking screws, and six (6) intact locking screws (parts 413.375s, 413.342s, 413.334s, 413.350s, 413.375s-x2).The extraction screws appear to have fragmented tip sections.Throughout the removal procedure, this breakage can occur because of device overloading situations.All the three carbide drill bits show signs of use on the surface and tip sections, but no material is broken off.The received plate shows extreme damages of the surface and two holes enlarged by drilling.The two unknown locking screws show damage to the head sections, likely due to drilling out the head during extraction.All six of the received locking screws are intact and undamaged.Based on the visible damages, design documentation for the screws and screw insertion/extraction were reviewed.Multiple factors can lead to technical difficulties during removal of locking compression plates (lcp) fixed with locking screws.These factors include, but are not limited to: wrong torque or angulation of the screw during insertion leading to cold-welding between the plate and the screw thread, or proteins forming a bond between the plate and screw thread.Some of these factors are patient specific factors or depend on the proper care of the surgeon, and can thus not be investigated.The root cause analysis can, therefore, not be determined.No final statement about the cause of such issues during lcp removal can be made.No manufacturing related failures could be detected.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

Clarification: device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that a patient underwent a tomofix plate and screw removal procedure on (b)(6) 2015.During the procedure, the surgeon encountered difficulty while extracting the locking screws from the c- and d- holes as those screws had been firmly fixed within the plate.The extraction screws utilized to remove the implanted screws broke during the process.At this point, the surgeon temporarily halted the attempt to remove those two screws and moved on to the other locking screws within the plate.A carbide drill was later employed to assist in the removal of the stuck screws.The drill was successfully able to break down the remaining extraction and locking screws.However, metal debris generated throughout the process spread into the patient's muscle fibers.The surgeon removed as much of the debris as could be seen, but x-ray imaging indicated that a lot of debris remained in situ.The surgeon does not believe the metal debris will cause problems and/or require future treatment.Due to the thickness of the plate and the (intra-operatively) broken screws, the procedure was extended by approximately three and a half (3 1/2) hours.The patient has reportedly been stable thus far.This report is 2 of 4 for (b)(4).

• Brand Name: CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS
• Type of Device: EXTRACTOR
• 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: 5279070
• MDR Text Key: 33097246
• Report Number: 9612488-2015-10620
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• 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: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309.530
• Device Lot Number: 9375810
• Other Device ID Number: (01)07611819018457(10)9375810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2015
• Initial Date FDA Received: 12/09/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 64 YR