MAUDE Adverse Event Report: SYNTHES BETTLACH EXTRACT-SCREW CONI F/SCR Ø4.5+6.5; EXTRACTOR

Catalog Number 309.530

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 05/26/2017

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Device malfunctioned intra-operatively and was not implanted / explanted.(b)(4).The tip of the extraction screw broke off in the locking screw during the attempted removal of the locking screw.The tip of the extraction screw remains in the patient inside the locking screw.The extraction screw is the non-implant grade.The subject device has been received by the manufacturer and is currently undergoing investigation.The results of the investigation are pending completion and will be submitted in a supplemental report.Device history records review was conducted.The report indicates that the 309.530 / l084157.Manufacturing location: (b)(4).Manufacturing date: 08.Sep.2016.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: the reported extraction screw was used in removal surgery for lcp df (lcp distal femur) on (b)(6) 2017.It was reported that the patient felt uncomfortable with the surgical area, so the surgeon checked and found three locking screws had been slightly extruded.(this portion of the complaint is reported in (b)(4)).During the removal surgery of those extruded screws, two of them were removed.While the surgeon was trying to remove the 3rd screw, threads of the screw head became stripped, he then used the extracting screw in question for removing the 3rd screw.The extraction screw broke, and the fragmented tip stuck in the head of the 3rd screw.Although the surgeon took measures to remove the 3rd screw, all the trials failed.Since the fragmented tip did not stick out of the screw head, he closed the incision, leaving the 3rd screw inside the patient¿s body.The surgery was delayed by 30 minutes.Patient outcome was good, no additional medical intervention was required.This complaint involves 2 parts.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

A manufacturing evaluation was completed: the part was received broken.As some of the extraction screw is still in the screw head we did not received the complete extraction screw.The device history records were reviewed and no deviations, irregularities or non-conformances were found which could lead to the complaint condition.It was found that the used raw material has fulfilled the specifications.As relevant for the complaint condition the hardness and the outer diameter were identified and measured.Both measurements were performed near the breakage.All dimensions, related to the complaint description as a failure source where checked, and there were no deviations found.The instrument meets all the specifications required.On the basis of the investigation the complaint is confirmed because the product was damaged as described above; however, no manufacturing issue could be found.No indication for material, manufacturing or design related issue was found.Device is an instrument and is not implanted/explanted; 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: EXTRACT-SCREW CONI F/SCR Ø4.5+6.5
• 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6660594
• MDR Text Key: 78176624
• Report Number: 9612488-2017-10279
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 07611819018457
• UDI-Public: (01)07611819018457(10)L084157
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 05/29/2017

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: L084157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2017
• Initial Date FDA Received: 06/22/2017
• Supplement Dates Manufacturer Received: 07/03/2017
• Supplement Dates FDA Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2016
• 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