MAUDE Adverse Event Report: SYNTHES MONUMENT 6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM; REAMER

Catalog Number	357.403
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.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: a review of the device history records was completed based upon provided part and lot numbers for the complainant device.Results are as follows: dhr review for part #357.403, synthes lot#u120002, release to warehouse date: 07-jun-2010, 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 the following: a 6.0mm/10mm stepped cannulated drill bit was broken during surgery on (b)(6) 2017.There was no generation of fragments from broken device.There was no delay in surgery.There was no patient harm.This complaint involves one device.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 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
A product development investigation was performed.The 357.403, lot number u120002, 6.0mm/10.0mm stepped drill bit cannulated/large qc/435mm was returned with a broken tip.The tip is missing an approximately 4.8 mm x 1.0 mm x 4.4 mm (l x w x h) fragment.The location of the broken fragment is unknown.This complaint is confirmed.A visual inspection under 5x magnification, device history record (dhr) review, and drawing review were performed as part of this investigation.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned device is already broken at the tip.The 357.403 6.0mm/10.0mm stepped cannulated drill bit is an instrument routinely used in the titanium trochanteric fixation nail (tfn) system.It is intended for use in dense bone to prepare a path for the full length of the head element during tfn procedures.It was reported that the instrument "was broken during surgery." this condition is confirmed.The balance of the returned device is in fair condition, the flutes on the drill bit are burred and show signs of wear.Although a definitive root cause could not be determined, it is likely that this complaint condition was due to excessive force applied to the tip of the device and/or over 7 years of consistent use.Relevant drawing was reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.During the investigation no product design issues or discrepancies were observed that may have contributed to the 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.

• Brand Name: 6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6606943
• Report Number: 1719045-2017-10526
• Device Sequence Number: 1088841
• Product Code: HTO
• UDI-Device Identifier: 10886982196262
• UDI-Public: (01)10886982196262(10)U120002
• 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
• Report Date (Section B): 05/11/2017

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: 357.403
• Device Lot Number: U120002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2017
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: Not provided; 06/28/2017
• Initial Report FDA Received Date: 06/01/2017
• Supplement Report FDA Received Date: 06/23/2017; 06/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1