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

Catalog Number	03.632.074
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Patient Involvement (2645)
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.Part #: 03.632.074, lot#: 6457244 (non-sterile) - t-handle t25 stardrive shaft f/matrix - long.Quantity (b)(4).Incoming inspection meet specification.Universal punch certificate of compliance & certificate of test meets specification.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Manufacturing location: supplier: (b)(4), packaged by: (b)(4).Manufacturing date: 29-apr-2011.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 is reported during routine inspection of devices, the tips of three (3) matrix screwdriver shafts were found to be stripped.No patient or surgical involvement.This report is for one (1) matrix stardrive shaft.This is report 2 of 3 for (b)(4).
Additional Manufacturer Narrative
A product investigation was completed: the returned instruments were evaluated at customer quality and the complaint condition was able to be confirmed for all parts but 03.632.074 lot 7901816.The unconfirmed screwdriver was returned in good condition with no damage to the tip.The tips of the remaining screwdrivers were stripped as the blades were dented in and pushed proximally.Although the definitive root cause could not be determined with the provided information, it is likely that excessive force over the course of the devices¿ life contributed to the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, device history record (dhr) review, and drawing review were performed as part of this investigation.This complaint is confirmed.Replication of the complaint is not applicable for the complaint conditions.Per the technique guide, the t-handle t25 stardrive screwdrivers are 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 (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 matrix deformity and degenerative technique guides state to always use the torque limiting handle (03.620.061) to reduce risk of damage to the t25 screwdriver shaft.The technique addition also cautions to never use a fixed or ratcheting t-handle screwdriver to remove locking caps.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 relevant product drawings were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.The design is adequate for its intended use when used and maintained as recommended, it did not contribute 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: T-HANDLE T25 STARDRIVE SHAFT F/MATRIX-LONG
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6537560
• Report Number: 1719045-2017-10379
• Device Sequence Number: 74908
• Product Code: HXX
• UDI-Device Identifier: 10705034719184
• UDI-Public: (01)10705034719184(10)6457244
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/06/2017

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: 6457244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 06/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1