MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG; SCREWDRIVERS

Catalog Number	03.632.074
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Date returned to manufacturer.(b)(6).Subject device has been received and is currently in the evaluation process.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 surgeon attempted to insert the pedicle screw into dense/hard bone, the tip of the screwdriver broke into a few pieces and the male threaded end of the holding sleeve broke.All fragments were retrieved.The procedure was completed with no delay utilizing similiar instrument.(b)(4).
Additional Manufacturer Narrative
Additional narrative: device manufacture date.Dhr review was completed.Part number: 03.632.074.Synthes lot number: 6631152.Supplier lot number: n/a release to warehouse date: 01-aug-2011.Expiration date: n/a.Manufactured by synthes (b)(4).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.Customer quality conducted an investigation of the returned device.The t-handle t25 stardrive shaft ¿ long (03.632.074) is one of ten t25 driver shafts intended to be utilized for screw insertion in the matrix system.Of the ten t25 drivers available in the system, only four are intended for final tightening/loosening of locking caps (03.632.002, 03.632.072, 03.632.400 and 03.632.401) with the use of a 10nm torque limiting ratchet handle (03.620.061) and a countertorque (03.632.049).The following caution is noted: ¿never use fixed or ratcheting t-handle screwdriver for this technique.If the torque limiting attachment is not used when using any of the stardrive shaft options breakage of the driver may occur and could potentially harm the patient.¿ the returned driver was examined and the complaint condition was able to be confirmed as the device was found to have a broken distal tip with segments of the lobes missing.No definitive root cause was able to be determined; the failure mode is consistent with the application of excessive torque with the tip is not fully seated in the screw¿s drive recess.The complaint condition was unable to be replicated due to post-manufacturing damage.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 devices.No dimensional analysis could be performed due to post-manufacturing damage.A device history review, including material and hardness reviews, was performed for the returned instrument¿s lot number and no mrrs, ncrs or complaint-related issues were identified with the lot number 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 condition.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: T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7154212
• Report Number: 2939274-2017-50487
• Device Sequence Number: 1447430
• Product Code: HXX
• UDI-Device Identifier: 10705034719184
• UDI-Public: (01)10705034719184(10)6631152
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 11/29/2017

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: 03.632.074
• Device Lot Number: 6631152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1