MAUDE Adverse Event Report: SYNTHES MONUMENT DRILL STOP; GUIDE

Catalog Number	357.405
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.No patient involvement reported.Implant and explant dates: device is an instrument and is not implanted/explanted.Initial reporter facility phone number: (b)(6).Device history records review was conducted.The report indicates that the: dhr review for: dhr review for part #357.405, lot #7421346.Release to warehouse date: 4-sep-2013.Expiration date: n/a.(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.Subject device has been received and the returned device shows signs of minor surface wear which does not impact functionality.The plunger is able to be depressed appropriately.The returned lot# um28415) which was confirmed to be in specification at the measuring steps.The outer diameter at the measurement points was measured to be 9.99mm which respectively is within the specification of measured using mitutoyo -caliper.The drill stop is able to engage with the drill bit appropriately and does not slide along the drill bit when engaged.The complaint is not confirmed, and is not replicated.The drill stop is able to engage with the drill bit appropriately and does not slide along the drill bit when engaged.A visual inspection, drawing review and dhr review were performed as part of this investigation.No definitive root cause was able to be determined.No product failures were observed during investigation.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 complaint condition.The complaint is not confirmed, and is not replicated.The returned parts were determined to be suitable for the intended use when employed.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: reported the following event: it was reported that the drill stop doesn¿t click correctly and doesn¿t stay in place.The issue occurred on (b)(6) 2016.In addition, the power wasn¿t working correctly on the small battery drive.It would stop for a short time and then start back up.This occurred when testing the device prior to the surgery.The patient was not in the operating room.Another device was used.This had no impact on the surgery or the patient.The procedure was completed successfully.It was also reported that the drill stop doesn¿t click correctly and doesn¿t stay in place.The issue occurred on (b)(6) 2016 prior to surgery.There was no patient involvement.Procedure was successfully completed.This complaint involves one (1) device.Concomitant devices reported: unknown drill bit (part # unknown, lot # unknown, quantity # unknown) this report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device 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
Update 03 feb 2017: ¿it was reported that the drill stop doesn¿t click correctly and doesn¿t stay in place.The issue occurred on (b)(6) 2016 prior to surgery.There was no patient involvement and no issues with the small battery drive.Procedure was successfully completed.¿.

• Brand Name: DRILL STOP
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6304042
• Report Number: 1719045-2017-10083
• Device Sequence Number: 760050
• Product Code: FZX
• UDI-Device Identifier: 10886982196286
• UDI-Public: (01)10886982196286(10)7421346
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2016

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: 357.405
• Device Lot Number: 7421346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 02/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN DRILL BIT, PART, LOT & QTY UNKNOWN