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

Catalog Number	03.632.052
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided for reporting.Device is an instrument and is not implanted / explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device history records review has been requested.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 that on (b)(6) 2018, patient underwent surgery for posterior spinal fusion.During the surgery, the short screwdriver shaft was stripped and was difficult to lock on the set screws and cross connector.Another short screwdriver shaft was used to complete the procedure.There was a ten-minute surgical delay.There was no adverse effect to the patient.Patient outcome was reported as fine.Concomitant devices reported: set screws (part #: unknown, lot#: unknown, quantity: unknown) cross connector (part #: unknown, lot#: unknown, quantity: 1).This report is for one (1) locking stardrive screwdriver shaft t15-short qc.This is report 1 of 1 for (b)(4).
Event or Problem Description
The procedure was completed successfully.No other medical intervention was required.
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.Additional narrative: event: additional information provided.Part: 03.632.052; synthes lot: 9807569; supplier lot: n/a; release to warehouse date: september 18, 2015; expiration date: n/a; manufactured by synthes monument; no nonconformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Investigation flows: device interaction/functional and damage: visual (appearance not as expected).Visual inspection: visual inspection of the returned screwdriver shaft performed at customer quality (cq) confirmed the condition of a worn/stripped tip, which agrees with the reported complaint condition.The distal stardrive tip shows post manufacturing cumulative wear in the form of rounded edges.Functional test: a functional test in effort to replicate the reported complaint condition of "the short screwdriver shaft was stripped and was difficult to lock on the set screws and cross connector" was not able to be performed at cq because the set screws and cross connector involved in the event were not returned.However, the stripped condition of the returned screwdriver shaft would contribute to the reported condition and therefore this complaint is confirmed.Document/specification review: the returned device was manufactured in september 2015.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Product design drawings for the matrix t-15 screwdriver shaft were reviewed during this investigation.The matrix t-15 stardrive screwdriver shaft (part#: 03.632.052) is a reusable instrument available in both the matrix deformity and matrix degenerative systems.In both instances, the device is one of two drivers, (the other being 03.632.055), utilized for the tightening/loosening of screws with t15 drive recesses.Within the matrix system, the screwdriver shafts are utilized for rod connectors, snap-on transconnectors, and parallel-connectors.No product design issues or discrepancies were observed.Dimensional inspection: a measurement of the distal stardrive tip on the returned screwdriver shaft was not attempted at cq due to the visually confirmed post manufacturing wear.The shaft diameter of the returned screwdriver shaft just proximal to the worn distal stardrive tip measured ø5.53mm at cq which is within specification of ø5.55 +/- 0.05mm per product design drawing.Conclusion: a definitive root cause for the distal tip of the returned screwdriver shaft becoming worn could not be determined based on the provided information.The most likely cause is cumulative wear during 3 years of use.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.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.

• Brand Name: LOCKING STARDRIVE SCREWDRIVER SHAFT T15-SHORT QC
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7772554
• Report Number: 8030965-2018-55618
• Device Sequence Number: 11045301
• Product Code: HXX
• UDI-Device Identifier: 10705034719085
• UDI-Public: (01)10705034719085
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2018

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: 9807569
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 09/17/2018
• 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: SEE EVENT DESCRIPTION