MAUDE Adverse Event Report: SYNTHES GMBH 2.5 THREADED GUIDE WIRE SPADE POINT 230; SCREW, FIXATION, BONE

Catalog Number	900.723
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
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 expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h4, h6: without a lot number the device history records review could not be completed.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.
Event or Problem Description
It was reported that on (b)(6) 2023, while drilling over a wire, the guide pin got stuck inside the dhs drill bit.A new wire was used, and also came out with the tap.The surgery was successfully completed.The surgeon passed one of the 4.5 cortex screws which was stainless steel into a titanium femoral nail.The surgeon mentioned he had not seen any issues with mixing metals like this and accepted the result.No adverse events occurred.Procedure was completed successfully without any surgical delay.No patient consequences.This report is for one (1) 2.5 threaded guide wire spade point 230.This is report 1 of 2 for complaint (b)(4).

• Brand Name: 2.5 THREADED GUIDE WIRE SPADE POINT 230
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17689939
• Report Number: 8030965-2023-11166
• Device Sequence Number: 6512803
• Product Code: HWC
• UDI-Device Identifier: 10886982256348
• UDI-Public: (01)10886982256348
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K982222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 900.723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 2.5 THREADED GUIDE WIRE SPADE POINT 230; UNK - DRILL BITS: TRAUMA; UNK - NAILS: FEMORAL; UNK - SCREWS: 4.5 MM CORTEX
• Patient Sex: Female
• Patient Weight: 56 KG