MAUDE Adverse Event Report: SYNTHES BRANDYWINE DRILL STOP; GUIDE

Catalog Number	357.405
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: event date: unknown.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.(therapy date): unknown.The subject device has been received and is currently undergoing investigation.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture: jul 6, 2007.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 is reported the drill stop is no longer stopping the drill bit.The issue was discovered in sterile processing when testing the device after cleaning.There was no patient or surgical involvement.Concomitant devices reported: drill bit (part number unknown, lot number unknown, quantity 1).This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.A product development investigation was performed for the subject device.The returned 357.405 lot number 5514369 drill stop for tfn step drill bit shows some markings and signs of wear but nothing that would impair its function.The device functions as designed.A visual inspection, functional test, and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.The cause of this complaint condition cannot be determined.The device was reported to not properly stop the drill bit.This complaint is unconfirmed.The complaint condition cannot be replicated.The device locks into a sample 356.821 lot number sx406898 drill bit and holds the device despite exerting a moderate amount of lateral force.The 356.821 pfn drill bit is near identical to the tfn 357.403 drill bit; the proximal end which interacts with the drill stop is identical.No design issue was found during the investigation of the drill stop.Drawing number 357_405 was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.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 BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 6327897
• Report Number: 2530088-2017-10037
• Device Sequence Number: 16414312
• Product Code: FZX
• UDI-Device Identifier: 10886982196286
• UDI-Public: (01)10886982196286(10)5514369
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2017

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: 5514369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/13/2017
• Supplement Report FDA Received Date: 03/17/2017
• 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, QUANTITY 1