MAUDE Adverse Event Report: SYNTHES HAGENDORF STRAIGHT TIP T25 DRIVER-LONG; SCREWDRIVERS

Catalog Number	03.632.401
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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.Manufacturing site: (b)(4).Manufacturing date: 31.Aug.2016.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 a patient underwent surgery on (b)(6) 2017 for a transforaminal lumbar interbody fusion (tlif), level l4-5, and during final tightening of the locking caps, the screwdriver stripped.It was reported that the surgeon was able to complete the tightening without any problems and it was unclear if he was aware of the issue.The stripped screwdriver was found post operatively when cleaning up the instruments.The patient was implanted with an interbody spacer, 2 rods, 4 pedicle screws and 4 locking caps.The surgery was completed successfully, without delay, and the patient reported as stable.Concomitant devices: matrix locking cap without saddle (part #09.632.099, lot #unknown, quantity 4).This complaint is for one (1) screwdriver this is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A product investigation was performed on the subject device part #03.632.401, lot #l074225.The distal tip of the returned driver was confirmed to be severely stripped.The flanges do not appear to be bent or twisted in either direction, but are stripped in a way which possibly could be caused by impact to the driver downward onto the screw.The balance of the device shows surface wear which does not impact functionality.A visual inspection, drawing review and device history record (dhr) review were performed as part of this investigation.The complaint is confirmed.Replication is not applicable as the device is already stripped.No additional malfunctions were observed during investigation.Relevant drawings were reviewed during investigation.There were no issues during the manufacture of this product that would contribute to this complaint condition.The design history was not found to impact the complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned parts were determined to be suitable for the intended use when employed.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: STRAIGHT TIP T25 DRIVER-LONG
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• MDR Report Key: 6449638
• Report Number: 3003875359-2017-10158
• Device Sequence Number: 10918005
• Product Code: HXX
• UDI-Device Identifier: 10705034719924
• UDI-Public: (01)10705034719924(10)L074225
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/14/2017

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: 03.632.401
• Device Lot Number: L074225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 05/05/2017
• 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: LOCKING CAP(PART 09.632.099, LOT UNKNOWN, QTY 4)
• Patient Age: 68 YR
• Patient Weight: 96