MAUDE Adverse Event Report: SYNTHES GMBH 2.0MM KIRSCHNER WIRE THREADED SPADE POINT TIP 280MM; PLATE, FIXATION, BONE

Model Number	292.699
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.Event details, initial reporter information, and additional information related to the medical device(s) are reported on the user facility report.Additional device product codes: hwc, jds.Complainant part is not expected to be returned for manufacturer review/investigation.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.Corrected information from user facility report.
Event or Problem Description
This report is against user facility medwatch number mw5114313.The only information contained in this report is correction or additional information.This report is for one (1) 2.0mm kirschner wire threaded spade poin this is report 1 of 1 for complaint (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.Part# 292.699, lot # 3l85812, manufacturing site: werk balsthal, release to warehouse date: 08 mar 2019, expiration date: na.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were 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
There was no surgical delay related to the event.The surgery was successfully completed.The patient status/ outcome: procedure completed with no harm to patient.

• Brand Name: 2.0MM KIRSCHNER WIRE THREADED SPADE POINT TIP 280MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BALSTHAL; dornacherstrasse 20; balsthal CO 4710 ; SZ 4710
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 16368840
• Report Number: 8030965-2023-01775
• Device Sequence Number: 12605051
• Product Code: HRS
• UDI-Device Identifier: 10886982180834
• UDI-Public: (01)10886982180834
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K962047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup

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: 292.699
• Device Catalogue Number: 292.699
• Device Lot Number: 3L85812
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 105 KG