MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH ANGLED STARDRIVE SCREWDRIVER T8 WITH SLEEVE/SELF-RETAINING; APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

Catalog Number	03.617.900
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.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 propeller shaft broke as the tip of the screwdriver was placed on the screw in the attempt to turn the screw.Surgical delay was fifteen (15) minutes since no other instrument was available.No patient harm reported.No further information available this report is for one (1) 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.E1: update to initial reporter contact information.D8, h5: correction to report as the device is not labeled for single use.D10, h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.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
Updated event description concomitant device reported: unknown screw (part #: unknown, lot #: unknown, quantity: 1).
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.H11: corrected data: g4: awareness date reported on follow up 2 report as january 07, 2020 but should have been june 03, 2020.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.Investigation site: cq zuchwil selected flow: damage.Visual inspection: our investigation has shown that only part with article 03.617.900.001 (screwdriver t8 selfh.W cardan joint) was received.The device is broken at its movable joint.Furthermore there are slightly signs of use visible on the entire surface.The observed damage is consistent with the reported complaint condition as such the complaint condition can be confirmed.All features related to the reported complaint condition were reviewed and no other issues were identified.Dimensional inspection: a dimensional test is not appropriate, since all complaint-relevant dimensions can no longer correspond to the valid technical drawings specifications due to the damage incurred.Document/specification review: comparing the actual released drawing: with the received device, we can confirm post-manufacturing damages.- no further manufacturing review could be performed as no lot number was made available investigation conclusion: this complaint is confirmed as the tip of the device has broken off.Additionally, the holding sleeve and the sleeve components are missing.Based on the provided information we are not able to determine the exact cause of this breakage.The cause for the complaint is most likely associated with the application of excessive force during screw insertion/final tightening and/or rough handling.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.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 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: APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9716585
• Report Number: 8030965-2020-01175
• Device Sequence Number: 11545473
• Product Code: HWQ
• UDI-Device Identifier: 07611819933071
• UDI-Public: (01)07611819933071
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K152239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/07/2020

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: 03.617.900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 03/31/2020; 01/07/2020; 06/22/2020; 07/01/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 04/13/2020; 06/17/2020; 06/22/2020; 07/01/2020
• 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