MAUDE Adverse Event Report: SYNTHES MONUMENT 1.5MM DRILL BIT/QC/85MM; INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH

Catalog Number	310.15
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Additional classification codes: gff, gfa, hsz.Device is an instrument and is not implanted/explanted.A device history record review was performed for part: #310.15 -synthes lot # u253058.Release to warehouse date:14nov2016.Expiration date: na.Supplier: (b)(4).No nonconformances (ncrs) were generated during production.Review of the device history records showed that there were no issues during the manufacturing of this product that would contribute to this complaint condition.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.(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 during a bunion surgery on (b)(6) 2017, the 1.5 mm drill bit tip broke inside the 2.0 mm/1.5 mm double drill sleeve guide.As the surgeon was drilling in the far cortex of the bone, using the lag screw technique, as he attempted to drill with the drill bit thru the double drill guide the tip portion of the drill bit broke off inside the drill guide.The entire fragment was retained inside the drill guide.Additional images were taken to ensure that no other fragments were generated.Due to this event no additional time was added in the operating room.Surgery was completed successfully and patient is reported in stable condition.Concomitant device: 2.0 mm/1.5 mm double drill sleeve (item # 312.22, lot 2038, quantity 1 each).This is report 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.This complaint is confirmed.The returned drill bit is broken.A portion of the drill bit remains lodged inside the returned drill guide.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the returned drill bit is already broken.No new malfunctions were identified as a result of the investigation.A visual inspection under 5x magnification, dimensional inspection of feature(s) related to this complaint, and drawing review were performed as part of this investigation.The returned drill bit is broken.The break is transverse and the material composition appears homogeneous when viewed under 5x magnification.A portion of the drill bit remains lodged inside the returned drill guide.The outside diameter of the drill bit near the break was measured as 1.491mm at cq (micrometers om521) which is within specification of 1.475mm - 1.5mm per drawing.Drawing was reviewed during this investigation.No product design issues or discrepancies were observed.The root cause is most likely due to off-axis force leading to drill bit breaking.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.The following device was returned as a concomitant device without an alleged complaint condition.Upon visual inspection there is no evidence that this device contributed to the complaint condition, and therefore no additional investigation will be performed on this device.Part #: 312.22 drill guide, lot #: 2038, quantity: 1.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/QC/85MM
• 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: 6438765
• Report Number: 1719045-2017-10265
• Device Sequence Number: 19016469
• Product Code: HWE
• UDI-Device Identifier: 10886982186027
• UDI-Public: (01)10886982186027(10)U253058
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 310.15
• Device Lot Number: U253058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/09/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 04/26/2017
• 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: PART # 312.22, LOT# 2038, QTY 1 EACH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR