MAUDE Adverse Event Report: SYNTHES GMBH 3.0MM TI HEADLESS COMPRESSION SCREW 16MM/SHORT THREAD-STER; SCREW,FIXATION,BONE

Catalog Number 04.226.016S

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2020

Event Type  malfunction  

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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent surgery with the screw in question.During the screw insertion, the screw couldn't be inserted completely.The surgeon gave up inserting the screw.The surgery was completed successfully without any surgical delay using a new screw.The bone quality was reported as not good.The patient outcome was reported as stable.No further information is available.Concomitant devices reported: unknown screwdriver (part# unknown, lot# unknown, quantity# 1).This report is for one (1) 3.0mm ti headless compression screw 16mm/short thread-ster.This is report 2 of 2 for (b)(4).

• Brand Name: 3.0MM TI HEADLESS COMPRESSION SCREW 16MM/SHORT THREAD-STER
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10861423
• MDR Text Key: 217136819
• Report Number: 8030965-2020-09018
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07611819794405
• UDI-Public: (01)07611819794405
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050636
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.226.016S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 YR