MAUDE Adverse Event Report: SYNTHES GMBH INNER SHAFT FOR REMOVAL SCREWDRIVER; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL

Catalog Number	03.647.972
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the inner shaft for removal screwdriver broke in the screw while replacing and changing trajectory of the screw.The surgeon let the tip in the screw inside the patient.It is unknown if there was a surgical delay.Patient outcome is unknown.Concomitant devices reported: unknown screw (part# unknown, lot# unknown, quantity 1).This report is for one (1) inner shaft for removal screwdriver.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H10 additional narrative: h3, h6: the investigation could not be completed, no conclusion could be drawn at the time of filing this report.Product was not available to return and customer retaining the product.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.
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.Visual inspection: the inner shaft f/screw removal screwdriver (p/n: 03.647.972, lot #: 40p5980) was returned and received at us cq.Upon visual inspection, it was observed that the distal tip was broken and not returned.There were some scratches on the device but have no impact on the device functionality.The reported embedded device cannot be confirmed as no x-rays were provided.No other issues were observed with the returned device.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed innerdrive removal complete: se_229522, rev.E/d.Investigation conclusion the complaint condition was confirmed for the inner shaft f/screw removal screwdriver (p/n: 03.647.972, lot #: 40p5980).There was no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot - part number: 03.647.972, lot number: 40p5980, manufacturing site: haegendorf, release to warehouse date: 24 april 2020.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: INNER SHAFT FOR REMOVAL SCREWDRIVER
• Common Device Name: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11446039
• Report Number: 8030965-2021-01757
• Device Sequence Number: 3106388
• Product Code: OVE
• UDI-Device Identifier: 07611819436213
• UDI-Public: (01)07611819436213
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.647.972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 03/09/2021; 05/31/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/07/2021; 05/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA