MAUDE Adverse Event Report: SYNTHES GMBH 6.5MM TI RECON SCREW WITH T25 STARDRIVE 80MM-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.003.026S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from japan reports an event as follows: it was reported that on an unknown date approximately 3.5 years ago, the patient underwent implant of a femoral nail/a2fn.On (b)(6) 2024 following removal of the nail implant, the most proximal hip screw was attempted to be removed but it stood still.The surrounding tissue and callus were removed but the screw in question would not turn.After that, the distal hip screw, distal locking screw and end cap were extracted.There were continued attempts to remove the screw in question but it was still unsuccessful, a different screwdriver was used and forceps were used, but removal could not be achieved.Because of the attempts to remove the screw, surgical time was extended for 3 hours.Ultimately the procedure ended with wound closure.The patient outcome was stable.On (b)(6) 2024 extraction surgery was successfully performed as bone fusion was achieved.No further information is available.This report is for a 6.5mm ti recon screw with t25 stardrive 80mm-sterile.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.

• Brand Name: 6.5MM TI RECON SCREW WITH T25 STARDRIVE 80MM-STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohnackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18895469
• Report Number: 8030965-2024-03581
• Device Sequence Number: 7477247
• Product Code: HSB
• UDI-Device Identifier: 10886982081568
• UDI-Public: (01)10886982081568
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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 Catalogue Number: 04.003.026S
• Device Lot Number: 1L91768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2018
• 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: UNK - END CAPS: FEMORAL NAIL; UNK - FORCEPS; UNK - SCREWDRIVERS; UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: TRAUMA
• Patient Sex: Unknown