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

Catalog Number 309.530

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/06/2021

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that the patient underwent revision surgery on (b)(6) 2021, due to unknown reason.During the procedure, a screw couldn¿t be removed.The surgeon tried to remove the screw with the two extraction screws, but both extraction screws were broken at their neck, and the screw couldn¿t be removed.The surgeon gave up removing the implants and closed the incision with the implants and the fragment of the extraction screw still in the body.The surgery was completed with thirty (30) minutes delay.This report is for a conical extraction screw for large screws & 4.9mm bolts.This is report 1 of 3 for (b)(4).

• Brand Name: CONICAL EXTRACTION SCREW FOR LARGE SCREWS & 4.9MM BOLTS
• Type of Device: EXTRACTOR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11752362
• MDR Text Key: 248205111
• Report Number: 8030965-2021-03458
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 7611819018457
• UDI-Public: (01)7611819018457
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309.530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: EXTRACT-SCREW CONI F/SCR Ø4.5+6.5; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR