MAUDE Adverse Event Report: SYNTHES TUTTLINGEN 2.0MM HEX SCREWDRIVER; SCREWDRIVERS

Catalog Number	03.820.143
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.No patient involvement reported.Device is an instrument and is not implanted/explanted.Date returned to manufacturer.Additional reporter's phone number: (b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Device history records review was conducted.The report indicates that the: manufacturing date: 27-jul-2008 (25 parts) and 08-sep-2008 (76 parts).Expiration date: na.Review of the device history record of tuttlingen showed that there were no issues at the time of manufacturing of this device that would contribute to the issue outlined in this complaint.A review of inspection records and certifications, confirm that the, hardness testing and final product met inspection records, certification.All 101 parts of the lot were checked 100% for important features at the final inspection on 20-jun-2008.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
The service and repairs department documented that the tip is broke in a trial implant extra large deep.Also, the tip is broken on a 2.0mm hex screwdriver.Both issues were found during inspection of a set.Both items are non-repairable.There was no patient involvement.This complaint involves two devices.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A product investigation was performed.The returned screwdriver was examined and the complaint condition could be confirmed as the distal tip was found to be broken and missing a segment which was found retained within the drive recess of the returned trial implant.No definitive root cause was able to be determined as method of use at time of failure is unknown.The remaining distal tip of the shaft shows twisting consistent with tightening, as such it is likely to excessive force was applied causing the device to deform and then fail.The complaint condition was unable to be replicated due to post-manufacturing damage.The trial implant was found to be intact and without identifiable defect or deficiency.No further investigation will be completed as the complaint allegation related to the trial is unconfirmed.A visual inspection, drawing review and device history review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.The 2.0mm hex screwdriver (03.820.143) is a component of the prodisc-c instrument and implant set (01.820.003) which is utilized for single level spinal arthroplasty from c3-c7.The screwdriver is utilized during trialing to back out the trial stop, allowing the trial to advance more posteriorly.Relevant drawings for the returned device were reviewed.The following dimensional analysis was completed: approximately 2mm of the distal tip was found to be broken and not returned.Length of shaft from the radius which interacts with the handle to the tip is 118mm per relevant drawing.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.

• Brand Name: 2.0MM HEX SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• MDR Report Key: 6905757
• Report Number: 9680938-2017-10134
• Device Sequence Number: 10975752
• Product Code: HXX
• UDI-Device Identifier: 10705034731803
• UDI-Public: (01)10705034731803(10)T927427
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 09/13/2017

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: 03.820.143
• Device Lot Number: T927427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 11/08/2017
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1