MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 42MM-STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	412.215S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Device history report.Part: 412.215s.Lot number: 161p614.Manufacturing site: (b)(4).Release to warehouse date: 29 jun 2021.Expiration date: 01 jun 2031.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.Product was not returned.Based on the information available, it has been determined that no corrective and 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 or Problem 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 1 of 3 for (b)(4).This report is for a locking screw.

• Brand Name: 5.0MM TI LOCKING SCR SLF-TPNG W/T25 STARDRIVE 42MM-STERILE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 14027875
• Report Number: 8030965-2022-02210
• Device Sequence Number: 12276180
• Product Code: KTT
• UDI-Device Identifier: 10886982275424
• UDI-Public: (01)10886982275424
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K000682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial 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
• Operator of Device: Health Professional
• Device Model Number: 412.215S
• Device Catalogue Number: 412.215S
• Device Lot Number: 161P614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HAND LRG W/QUICK-COUPL; SCRDRIVERSHAFT T25 L241
• Patient Sex: Unknown