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

Catalog Number	03.632.004
Medical Device Problem Codes	Break (1069); Device Operates Differently Than Expected (2913)
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.No service history review can be performed as part number 03.632.004 with lot number 6670694 is a lot/batch controlled item.The manufacture date of this item is may 18, 2011.The source of the manufacture date is the release to warehouse date.The service history review is unconfirmed.Device history records review was completed for part# 03.632.004, lot# 6670694.Supplier: (b)(4), release to warehouse date: may 18, 2011.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device was received and the product evaluation is in progress.No conclusion can be drawn.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
The service and repair (s&r) department documented that synthes evaluation equipment of t-handle t25 stardrive shaft f/matrix-standard has a functional issue, unspecified.This issue was identified during inspection activities of the evaluation set.There were no issues reported by the customer.Device returned to manufacturer.Upon examination, it was found that the distal tip of device was broken and missing.This report is for one (1) stardrive shaft f/matrix-standard.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A product investigation was completed: the returned screwdriver was found to have a broken distal tip.The remainder of the device is in good condition.No non-conformance reports were generated during production.Review of device history records (dhr) showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.A visual inspection, drawing review and dhr review were performed as part of this investigation.The complaint is confirmed.Replication of the complaint condition is not applicable as the device is already broken.Per the technique guide, the t-handle t25 stardrive shaft 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 (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 relevant drawings were reviewed during investigation.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.No definitive root cause was able to be determined.The broken tip is likely related to application of excessive torque.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: 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: 6253932
• Report Number: 1719045-2017-10023
• Device Sequence Number: 19012942
• Product Code: HXX
• UDI-Device Identifier: 10705034718699
• UDI-Public: (01)10705034718699(10)6670694
• 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
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2016

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: Health Professional
• Device Catalogue Number: 03.632.004
• Device Lot Number: 6670694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/16/2017
• Supplement Report FDA Received Date: 01/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1