MAUDE Adverse Event Report: SYNTHES MONUMENT CROSS PINNED HEX SCREWDRIVER SHAFT/QC; SCREWDRIVERS

Catalog Number	03.614.039
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known reported patient involvement associated with the complained event.Unknown when device malfunctioned.Device is an instrument and is not implanted/explanted.A device history record (dhr) review was performed for part#: 03.614.039, lot#: 7927897: release to warehouse date: 20-may-2015, expiration date: n/a, supplier: (b)(4): no non-conformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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 during field inspection two (2) hexagonal screwdriver shaft were found to be worn and hard to use.There was no patient or procedure involvement.This report is for one (1) cross pinned hex screwdriver shaft.This is report 2 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
A product development investigation was performed.A visual inspection, device history review and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.The returned devices were examined and in each instance the complaint conditions were able to be confirmed as the cross pinned hex screwdrivers were found to be worn.The complaint conditions were unable to be replicated due to post-manufacturing damage.The threaded holding sleeve (03.614.017) is noted in the synapse oct system technique guide.The synapse system is utilized for posterior stabilization of the upper spine: craniocervical junction, cervical spine (c1-c7) and thoracic spine (t1-t3).The holding sleeve is a component of the screwdriver assembly, along with the cross-pinned hexagonal screwdriver shaft (03.614.039) and handle with quick coupling (321.107) are utilized for screw insertion.Relevant drawings for the returned instruments were reviewed.A dimensional analysis is not applicable due to observed post-manufacturing damage.A device history review, including material review, was performed for the returned instruments¿ lot numbers and no mrrs, ncrs or complaint-related issues were identified with the lot numbers which may have contributed to the complaint conditions.The material, material properties, and hardness of the returned part(s) were determined to be conforming at the time of manufacture and based on review of the associated/available dhr(s) and based on the details of the complaint and investigation of the returned part(s), additional material/hardness testing is not required.No definitive root cause was determined however the failure mode is typically associated with wear and tear and/or rough handling.The devices were manufactured in 2015 and are approximately 2 years old.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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
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: CROSS PINNED HEX SCREWDRIVER SHAFT/QC
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6866573
• Report Number: 1719045-2017-10916
• Device Sequence Number: 13640961
• Product Code: HXX
• UDI-Device Identifier: 10705034715070
• UDI-Public: (01)10705034715070(10)7927897
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2017

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: 03.614.039
• Device Lot Number: 7927897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Initial Date Received by Manufacturer: 08/24/2017
• Supplement Date Received by Manufacturer: 08/25/2017; 10/17/2017
• Initial Report FDA Received Date: 09/14/2017
• Supplement Report FDA Received Date: 09/22/2017; 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1