MAUDE Adverse Event Report: SYNTHES MONUMENT 1.5MM DRILL BIT/MINI QC/65MM; INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH

Catalog Number	310.141
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes: gfa, gff, hsz.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review: part number: 310.141, synthes lot number: u145578, supplier lot number: n/a, release to warehouse date: 19-dec-2011, expiration date: n/a, supplier: (b)(4).(b)(4) was generated during production for (b)(4) parts for which lot #u145578 received did not match lot #u144578 on package.After inspection of etch lot #s did match #u145578.Action taken was to inactivate lot master for #u144578 and notify inspector and dhr review.This non-conformance is not relevant to the complaint condition.Review of the device history record showed that there were no issues during the manufacture of the 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.
Event or Problem Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported the distributor noted two (2) broken drill bits.One (1) has a broken tip, the other is broken into three (3) pieces.No patient involvement was reported.This report is for one (1) 1.5 mm drill bit.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.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.
Additional Manufacturer Narrative
Product development investigation was completed.The investigation summary indicates that: article 310.141 lot u145578: the visual inspection has shown that approximately 1 mm from the fluted tip section is broken off.The broken tip was not returned for evaluation.There were no other damages or signs of misuse detected.The measurements of the hardness after the hardening procedure were within the specification.The used material was stainless steel as required.This lot of (b)(4) pieces was manufactured in december 2011 and we are not aware of any other complaint with this article- and lot combination.Based on provided information, we exclude any manufacturing related issue and we are not able to determine the exact cause which has led to this breakage.It is likely that a mechanical overloading situation, for example metallic contact or lateral stress, has caused the breakage.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.
Additional Manufacturer Narrative
Date added to complaint, originally reported on previous mw.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.

• Brand Name: 1.5MM DRILL BIT/MINI QC/65MM
• Common Device Name: INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 7007665
• Report Number: 1719045-2017-11157
• Device Sequence Number: 13954354
• Product Code: HWE
• UDI-Device Identifier: 07611819707993
• UDI-Public: (01)07611819707993(10)U145578
• 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,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/13/2017

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: 310.141
• Device Lot Number: U145578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 11/09/2017; 12/14/2017; 01/08/2018
• Initial Report FDA Received Date: 11/07/2017
• Supplement Report FDA Received Date: 12/05/2017; 01/04/2018; 01/08/2018
• Patient Sequence Number: 1