MAUDE Adverse Event Report: SYNTHES MONUMENT 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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is not known if patient was involved.Date of device breakage is not known.Device is an instrument and is not implanted/explanted.Hospital contact telephone: (b)(6).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 synthes lot# 6999713.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.Release to warehouse date: 26-nov-2012.Manufactured by (b)(4).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
Device report from synthes europe reports an event in (b)(6) as follows: it is reported the stardrive screwdriver shaft was received at the depuy synthes affiliate in (b)(4) with the handle tip broken.It is not known how device was broken or if there was patient involvement.This report is for one (1) stardrive screwdriver shaft.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Investigation summary: it was reported that the affiliate received a broken screwdriver stardrive (part 03.632.074, lot 6999713, mfg 26-nov-2012).The tip of the handle is broken.The returned instrument was evaluated at customer quality and the complaint condition was able to be confirmed.A spiral fragment approximately 6 mm in length had broken off from the distal tip of the screwdriver.The fragment was returned with the complaint.The remaining blades of the screwdriver still on main component were bent as a result of a counterclockwise force, indicating that the screwdriver was used for extraction.Replication of the complaint is not applicable as the malfunctions were visually confirmed.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.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.No new malfunctions were identified.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: 6537260
• Report Number: 1719045-2017-10377
• Device Sequence Number: 11169723
• Product Code: HXX
• UDI-Device Identifier: 07611819377301
• UDI-Public: (01)07611819377301(10)6999713
• Combination Product (Y/N): N
• 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,distri
• 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: 6999713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2017
• 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: 05/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1