MAUDE Adverse Event Report: SYNTHES MONUMENT 13.0MM CANNULATED DRILL BIT 300MM; INSTR,SURGICAL,ORTHO,PNEUMATIC POWERED & ACCESSORY/ATTACHMENT

Catalog Number	351.27
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device used for treatment, not diagnosis.Patient age & weight not provided for reporting.Device is an instrument and is not implanted/explanted.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 history records review was conducted.The report indicates the: dhr review: part # 351.27, synthes lot # u110553, supplier lot # u110553.Release to warehouse date: 07 oct 2009.Supplier: (b)(4).No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which 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
It was reported that a drill bit broke off into a drill chuck during an open reduction internal fixation (orif) intramedullary nail insertion of the femur on (b)(6) 2017.The drill bit broke into two pieces as the surgeon was drilling.The drill used was a stryker 7000.There was no reported surgical delay.Fragments did fall into the patient; but,were reported as easily removed and caused no delay or internal damage.The surgery was successfully completed using a new drill bit.A nail and (4) 5.0mm locking screws were implanted in the patient after the drill bit broke.The patient outcome was reported as great.A replacement was requested.Concomitant devices reported: a stryker 7000 drill (part number: unknown, lot number: unknown, quantity: 1).This report involves 1 device.
Additional Manufacturer Narrative
Concomitant medical products: a stryker 7000 drill (part number: unknown, lot number: unknown, quantity: 1).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
Additional device product codes: hwe, gfa, gff.A product investigation was performed.This complaint is confirmed, the device was returned broken in two pieces.A visual inspection, dimensional analysis, and drawing review were conducted as part of this investigation.Visual inspection at customer quality (cq) confirmed the reported complaint description.The device was received at cq in two pieces.A piece, 19.85 mm, broke off the proximal end of the drill bit.Further dimensional analysis of the inner and outer diameter of the device were not applicable due to post manufacture malformation.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.No further material testing will be conducted.Relevant drawings were reviewed during this investigation.No product design issues or discrepancies were observed.A definitive root cause for this complaint could not be determined.The device could have been used at an angle or off axis.Additionally, it was noted that the surgeon was using a stryker power drill.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition as the instrument is already broken.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: 13.0MM CANNULATED DRILL BIT 300MM
• Common Device Name: INSTR,SURGICAL,ORTHO,PNEUMATIC POWERED & ACCESSORY/ATTACHMENT
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• MDR Report Key: 6915569
• Report Number: 1719045-2017-11013
• Device Sequence Number: 19128095
• Product Code: HSZ
• UDI-Device Identifier: 10886982193797
• UDI-Public: (01)10886982193797(10)U110553
• 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,Followup
• Report Date (Section B): 09/14/2017

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: 351.27
• Device Lot Number: U110553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Initial Date Received by Manufacturer: 09/14/2017
• Supplement Date Received by Manufacturer: 10/05/2017; 11/08/2017
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 10/05/2017; 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR