MAUDE Adverse Event Report: SYNTHES MONUMENT T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-STANDARD; SCREWDRIVERS

Catalog Number	03.632.004
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reportedly there was no patient involvement.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.Part 03.632.004, lot 6755441: release to warehouse date: january 17, 2012.Supplier: (b)(4).No non-conformance reports 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 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
It was reported that upon routine inspection of field equipment it was discovered that the tips are worn out on four (4) t-handle t25 stardrive shaft screwdrivers.In addition, the threads on the distal end of a screwdriver sleeve were found to be broken.The broken piece remains somewhat attached to the device.There was no patient involvement.This is report 4 of 5 for (b)(4).
Additional Manufacturer Narrative
A product investigation was completed: a device history review was performed for the returned instruments¿ lot numbers and no material review reports, non-conformance reports or complaint-related issues were identified with the lot numbers which may have contributed to the complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint conditions.A visual inspection, complaint history review, drawing review, device history review and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.Parts 1-4: t-handle t25 stardrive shaft (03.632.004 x4): the returned drivers were examined and in each instance the drivers were found to have chipped distal tips with segments of the lobes missing from each driver.No definitive root cause was able to be determined; the failure mode of a chipped distal tip is consistent with the application of excessive torque with the tip is not fully seated in the screw¿s drive recess.Relevant drawings for the returned instruments were reviewed (both current revision and from the time of manufacture): top-level and shaft.The design, materials and finishing processes were found to be appropriate for the intended use of these devicespart 5: matrix holding sleeve ¿ standard with stop (03.632.123): the returned matrix holding sleeve (03.632.123) was examined and the complaint condition was able to be confirmed as the threaded tip was found to be cracked but intact.No definitive root cause was able to be determined; the failure mode is consistent with the application of an off-axis load while engaging a screw.No functional test was possible due to post-manufacturing damage.Relevant drawings for the returned matrix holding sleeve (03.632.123) were reviewed (both current revision and from the time of manufacture): top-level and inner shaft.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.Design changes were implemented in (b)(6) 2011 to address the failure mode of the holding sleeve threaded tips breaking.The tip geometry on the inner sleeve was changed to a more constant outer diameter in order to improve product performance; the returned instrument was manufactured after the implementation of these changes (october 2015).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.
Event or Problem Description
Upon examination of the devices by the manufacturer, it was noted that the distal drive tips of all of the returned t-handle drivers were found to be broken and missing pieces of the drive lobes.

• Brand Name: T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-STANDARD
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6185086
• Report Number: 1719045-2016-10926
• Device Sequence Number: 16400830
• Product Code: HXX
• UDI-Device Identifier: 10705034718699
• UDI-Public: (01)10705034718699(10)6755441
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2016

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: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 03.632.004
• Device Lot Number: 6755441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 01/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1