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 Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement reported.Date of device breakage is not known.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Dhr review for part #357.403, synthes lot#up51710.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.Release to warehouse date: 08-dec-2005, 09-dec-2005.(b)(4).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 reported that the tip of a 6.0mm/10.0mm stepped drill bit cannulated/large with quick coupling was found broken off in central sterile processing.No known procedure or patient involvement.This report is for one (1) 6.0mm/10.0mm stepped drill bit (b)(4).
Additional Manufacturer Narrative
Customer quality conducted an investigation of the returned device.A visual inspection, 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 already has a broken 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.The device was returned and it was reported that "the tip of a 6.0mm/10.0mm stepped drill bit cannulated/large with quick coupling was found broken off " this condition is confirmed; the instrument was returned with an approximately 7.7 mm x 5.7 mm (l x h) fragment of the distal tip missing.The fragment(s) was not returned and the location of the fragment(s) is unknown.The balance of the returned device is in fair condition, there is no discoloration, but the edges of the helix blade are slightly burred.Dhr review for part #357.403, synthes lot#up51710 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.Drawing (mfg to current) were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.A dcrm review and/or occurrence rate calculation must be performed for all complaint parts which resulted in a classification of serious injury that were not generated from a literature article.Therefore, no dcrm calculation will be performed for this complaint.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 (i.E.From dense bone) and/or consistent use and cumulative wear over the part's lifetime (11+ years) causing material fatigue and breakage.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: 6807841
• Report Number: 1719045-2017-10811
• Device Sequence Number: 16176165
• Product Code: HTO
• UDI-Device Identifier: 10886982196262
• UDI-Public: (01)10886982196262(10)UP51710
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2017

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: UP51710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Initial Date Received by Manufacturer: 07/28/2017
• Supplement Date Received by Manufacturer: 09/01/2017
• Initial Report FDA Received Date: 08/21/2017
• Supplement Report FDA Received Date: 09/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1