MAUDE Adverse Event Report: SYNTHES MONUMENT LOCKING STARDRIVE SCREWDRIVER SHAFT T15-SHORT QC; SCREWDRIVERS

Catalog Number	03.632.052
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.(b)(6).The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 europe reports an event in (b)(6) as follows: it was reported during a lumbar canal stenosis (lcs) stabilizing procedure at l4-l5 on (b)(6) 2017, as surgeon was fixing a screw, the tip of the locking stardriver screwdriver shaft was stripped.Surgery was completed successfully with no delay and no harm to patient.Concomitant medical products: screw (part number unknown, lot number unknown, quantity 1).This report is for one (1) locking stardriver screwdriver shaft.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
(b)(4).Part #: 03.632.052, lot#: 6633504 (non-sterile) - locking stardrive screwdriver shaft t15-short qc.Quantity (b)(4).Raw material part 11146 lot 6459297 meet specification.Incoming final inspection and certificate of compliance received from (b)(4) meet specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing location: supplier - (b)(4), packaged by: (b)(4), manufacturing date: 29-aug-2011.Part #: 03.632.052, lot#: 6633504 (non-sterile) - locking stardrive screwdriver shaft t15-short qc.Quantity (b)(4).Components part 03.632.052 locking stardrive screwdriver lot 6633504 meet specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing location: supplier - (b)(4), packaged by: (b)(4), manufacturing date: 14-nov-2011 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
Manufacture investigation: dhr review of complained screw driver shows that this specific lot was released after complete final inspection with no findings in august 2011.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Visible inspection shows that the part is in faultless condition.Even there are some smart signs of multiple use visible at the torx tip, the instrument is still in faultless condition and its function is as intended.Carried out functional test of the two complained part could not reproduce the reported problem.The screw could be assembled and disassembled to the screw driver as intended without any problems.No product related issue could be identified.We are not able to identify the root cause for the reported problem.The screw driver is in faultless condition.Dhr review, no issue functional test, no issue visual inspection, small signs of wear and tear could be 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: LOCKING STARDRIVE SCREWDRIVER SHAFT T15-SHORT QC
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6578129
• Report Number: 1719045-2017-10482
• Device Sequence Number: 74895
• Product Code: HXX
• UDI-Device Identifier: 07611819379541
• UDI-Public: (01)07611819379541(10)6633504
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2017

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: 03.632.052
• Device Lot Number: 6633504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/19/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/19/2017
• Supplement Report FDA Received Date: 05/19/2017; 06/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1