MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC; SCREWDRIVERS

Catalog Number	03.614.019
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 (b)(4) reports an event in (b)(6) as follows: it was reported that the during a c2-c7 level posterior cervical fusion procedure performed on (b)(6) 2017; surgeon was torqueing off set screws with stardrive screwdriver shaft and the shaft stripped and surgeon was unable to torque.Second stardrive screwdriver shaft was used and the same thing happened.Surgeon used the t15 driver in the h2h kit and torqued off.The surgery was delayed by ten (10) minutes, there is no consequence for the patient.This report is for one (1) stardrive screwdriver shaft t15/self-retaining qc this is report 1 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
Device history record (dhr) review: manufacturing location: monument; manufacturing date: april 28, 2015; supplier: (b)(4).Part no: 03.614.019, lot # 7867540 (non-sterile) -stardrive screwdriver shaft t15/self-retaining qc.Quantity (b)(4).No nonconformance records (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Components reviewed: raw material part no: 11156, lot no: 5265803 received from (b)(4).Certificate of conformity from (b)(4) meet specification.Raw material receiving/put away checklist meet specification.Investigation summary: investigation selection: investigation site: (b)(4).Selected flow(s): 3.Damaged: visual | examples: deformed/bent/cracked.Visual inspection: upon visual inspection of the complaint device it can be seen that the part has no damage at all, as well as the distal (coupling part) and proximal (screw driver) have just a few/slight signs of usage (wear and tear).Furthermore, the article is in a very good condition.Summary: complained issue could not be replicated and/or confirmed based on the received part.Unfortunately we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place.To prevent such problems, it is necessary to operate according to the technique guide (b)(4).Based on the investigation findings, 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.
Additional Manufacturer Narrative
Manufacturing location: (b)(4).Manufacturing date: april 28, 2015.Supplier: (b)(4).No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.The component parts and raw material documentation was also reviewed and met specification.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: STARDRIVE SCREWDRIVER SHAFT T15/SELF-RETAINING QC
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7080814
• Report Number: 8030965-2017-50271
• Device Sequence Number: 19057533
• Product Code: HXX
• UDI-Device Identifier: 07611819968646
• UDI-Public: (01)07611819968646(10)7867540
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2017

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: 03.614.019
• Device Lot Number: 7867540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 01/16/2018; 09/04/2018
• Initial Report FDA Received Date: 12/04/2017
• Supplement Report FDA Received Date: 01/19/2018; 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR