MAUDE Adverse Event Report: SYNTHES GMBH ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number	03.617.900
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, during insertion of screw with zero-p va the angled screwdriver broke at the hinge of the drive mechanism.This caused the handle to turn but not the drive mechanism.No surgical delay.No fragments were generated.Procedure was successfully completed.There was no patient consequence.This report is for an angled stardrive screwdriver t8 with sleeve/self-retaining.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.Additional narrative: common device name: additional procode: kwq.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter occupation: initial reporter is a synthes employee.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.
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.H3, h6: part:03.617.900, lot 8502152, manufacturing site: werk hagendorf, release to warehouse date: 12 november 2013.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Service and repair evaluation: the customer reported that the 03.617.900, scrdriver t8 self-holding angl w/sleeve broke at the hinge of the drive mechanism.The repair technician reported that the inner shaft was broken, device failed to operate smoothly and cosmetic test failed.The cause of the issue is damaged component.Inner shaft was replaced.The item was repaired per the inspection sheet, passed synthes final inspection.And will be returned to the customer upon completion of the service and repair process.Finalized service record will be archived.The evaluation was confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.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: ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• 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 ; 3035526892
• MDR Report Key: 15873181
• Report Number: 8030965-2022-10306
• Device Sequence Number: 5398807
• Product Code: OVE
• UDI-Device Identifier: 10705034717142
• UDI-Public: (01)10705034717142
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K152239
• 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,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: 03.617.900
• Device Catalogue Number: 03.617.900
• Device Lot Number: 8502152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 11/28/2022
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: SPINE-US
• Patient Age: 65 YR
• Patient Sex: Unknown