MAUDE Adverse Event Report: SYNTHES MONUMENT CROSS PINNED STRDRV SCRWDRVR SHAFT SELF-RETAINING T15/QC; SCREWDRIVERS

Catalog Number	03.614.018
Medical Device Problem Code	Break (1069)
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.A device history record (dhr) review was performed for part# 03.614.018, lot# 6371373: release to warehouse date: july 26, 2010, supplier: (b)(4).No non conformance reports (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.The device has been 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
It was reported by service and repair department that synthes evaluation equipment - tip is broken - issue identified during inspection activities of the evaluation set.There were no issues reported by the customer.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
A product investigation was completed: the tip of the returned screwdriver was confirmed to be broken where the dowel pin passes through the tip.The broken fragment was not returned for investigation.A visual inspection, drawing review and device history record 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.No additional malfunctions were observed during investigation.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 most likely due to excessive torque during use.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.Reportedly there was no patient involvement.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: CROSS PINNED STRDRV SCRWDRVR SHAFT SELF-RETAINING T15/QC
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6377792
• Report Number: 1719045-2017-10181
• Device Sequence Number: 733333
• Product Code: HXX
• UDI-Device Identifier: 10705034714899
• UDI-Public: (01)10705034714899(10)6371373
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2017

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: 03.614.018
• Device Lot Number: 6371373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2017
• Supplement Report FDA Received Date: 04/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1