MAUDE Adverse Event Report: SYNTHES MONUMENT DRILL STOP; GUIDE

Catalog Number	357.405
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Additional narrative: 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: manufacturing location: dhr review for part # 357.405 lot # 4544093; release to warehouse date: 29april2003; expiration date: n/a; manufactured by synthes (b)(4).No ncrs were generated during production.Review of device history records 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 drill bit stop, malfunctioned during a surgical procedure.The drill bit does not stop at the desired chosen depth, prior to drilling the femoral neck.There was no reported harm to the patient, no surgical delay, and no fragments were generated.The surgery was successfully completed.This complaint involves one device.Concomitant device reported: unknown drill bit (part # unknown, lot # unknown, qty.1).This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
(b)(6).The device was received and the product evaluation is in progress.No conclusion can be drawn.Device history records review for the corrected lot has been requested.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.
Additional Manufacturer Narrative
Customer quality (cq) investigation: this complaint is not confirmed.The returned drill stop was received at cq showing minor wear marks.The plunger component/feature travels as intended.A visual inspection under 5x magnification, functional test, device history record (dhr) review and drawing review were performed as part of this investigation.Visual inspection: the returned drill stop was received at cq showing minor wear marks.The plunger component/feature travels as intended.Functional test: the returned drill stop was functionally tested with a known good stepped reamer (part# 356.821 lot#sx406898) at cq.The drill stop worked as intended on each drill step.Because the drill stop is symmetrical, it was tested in both orientations on the drill bit and functioned as intended "held position" in all locations.This complaint condition was not able to be replicated at customer quality (cq).No new malfunctions were identified.Complaint is unconfirmed, therefore a root cause could not be determined.It is possible that the reporter's stepped reamer/drill bit that mates with the returned drill stop is old /worn and caused the complaint condition.Device history records review was conducted.The report indicates that the: dhr review for part # 357.405 lot # 5551968; release to warehouse date: 02-oct-2007; expiration date: n/a; supplier: (b)(4).No ncrs were generated during production.Review of device history records showed that there were no issues during the manufacture of this product that would contribute to this complaint condition.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.
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DRILL STOP
• Common Device Name: GUIDE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6335632
• Report Number: 2530088-2017-10043
• Device Sequence Number: 885686
• Product Code: FZX
• UDI-Device Identifier: 10886982196286
• UDI-Public: (01)10886982196286(10)4544093
• 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,Followup,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: 357.405
• Device Lot Number: 5551968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/07/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 02/16/2017
• Supplement Report FDA Received Date: 04/03/2017; 04/12/2017; 04/18/2017
• 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 # UNKNOWN, LOT # UNKNOWN,