MAUDE Adverse Event Report: SYNTHES MONUMENT 0.25MM SLOTTED SCREWDRIVER BLD HEX COUPLING; SCREWDRIVES

Catalog Number	03.505.210
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Patient information not available for reporting.Device is an instrument and is not implanted/explanted.Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.Device history records review was conducted.The report indicates that the: dhr review for part #03.505.210, synthes lot#7766705.Release to warehouse date: 19-nov-2014, expiration date: n/a, supplier: (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 that would contribute to this complaint condition.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 on an event in (b)(6) as follows: it was reported that the tip of the screw driver was broken during the surgery on (b)(6) 2017.No further information was provided by the hospital.There is no information available about patient and surgical outcome, surgical prolongation or unknown if a fragment felt into the patients body.This complaint involves 1 part.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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 further reported that during a mandible plate removal surgery the surgeon felt it was difficult to remove the matrix mandible 2.0 mm locking screw using the reported screwdriver.The screw did not break but was difficult to remove from the patient¿s mandible.The surgery was completed successfully with no delay and no adverse consequence to the patient.

• Brand Name: 0.25MM SLOTTED SCREWDRIVER BLD HEX COUPLING
• Common Device Name: SCREWDRIVES
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6440798
• Report Number: 1719045-2017-10268
• Device Sequence Number: 10904077
• Product Code: HXX
• UDI-Device Identifier: 07611819333901
• UDI-Public: (01)07611819333901(10)77667
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2017

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: 03.505.210
• Device Lot Number: 7766705
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/07/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1