MAUDE Adverse Event Report: SYNTHES GMBH T25 STARDRIVE SCREWDRIVER SHAFT 241MM

Catalog Number 03.168.014

Device Problem Fitting Problem (2183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2022

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) 2021, the patient underwent open reduction internal fixation (orif) surgery with the femoral neck system (fns) implants.After the surgery, revision surgery was completed on (b)(6) 2022, due to the bone union failure, femoral neck shortening and pain.In this revision surgery, the surgeon had difficulty removing the fns implants.A handle/large with quick coupling and at25 stardrive¿ screwdriver shaft was used to remove the fns implants, but the implants could not be removed due to the distal screw being fixed firmly.Another company¿s screwdriver was used for the removal, and the screwdriver tip became stripped.It was suggested to use the insertion handle with force and attempt removal, but the surgeon chose to use a carbide drill.The plate came off, but the tip of screw remained in the bone.Another company's instrument was used, and residual fragments could be removed.The removal of implant for delayed union of femoral neck fracture and artificial head replacement were completed successfully without any surgical delay.This (b)(4) is linked to (b)(4) which reports about the bone union failure, femoral neck shortening and pain which occurred after the first surgery.(b)(4) reports about the event which occurred in the revision surgery.This is report 3 of 3 for (b)(4).This report is for a screwdriver shaft.

• Brand Name: T25 STARDRIVE SCREWDRIVER SHAFT 241MM
• Type of Device: SCREWDRIVER
• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14028197
• MDR Text Key: 288812846
• Report Number: 8030965-2022-02225
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

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: 03.168.014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: HAND LRG W/QUICK-COUPL; LOCKSCR Ø5 SELF-TAP L42 TAN