MAUDE Adverse Event Report: SYNTHES BETTLACH CONICAL EXTRACTION SCREW FOR 1.5MM & 2.0MM CORTEX SCREWS; EXTRACTOR

Catalog Number	309.510
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Dull, Blunt (2407)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Additional narrative: patient information is not available for reporting.Device is an instrument and is not implanted/explanted.(therapy date): unknown.The subject device has been received and is currently in the evaluation process.Upon initial inspection of the returned device, it was noted that the conical tip was broken off.A device history record review was performed for the subject device lot.Manufacturer: synthes (b)(4).Date of manufacture date: jan 15, 2007.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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 hardware removal procedure of a plate and one (1) broken screw on (b)(6) 2017, the spare reamer tube for the hollow reamer broke, the conical extraction screw for 1.5mm and 2.0mm cortex screws stripped, and the conical extraction screw for 2.7mm and 3.5mm cortex screws stripped during removal of the broken screw.Fragments generated by the broken screw upon removal.It is unknown if there was any delay in surgery and the patient outcome is unknown, it is unknown if the patient was revised with any new hardware.Anticipated routine x-rays were taken.The unknown plate and unknown quantity of unknown screws, including the one (1) screw that reportedly broke postoperatively, were not confirmed to have been manufactured by synthes.The manufacturer is unknown at this time.The date of implant is unknown.This complaint addresses the synthes instruments that reportedly malfunctioned during the hardware removal procedure.If additional information is obtained regarding the implants, this complaint will be updated and reported as necessary.Concomitant devices reported: plate (part # unknown, lot # unknown, quantity 1) screw (part # unknown, lot # unknown, quantity unknown).This report is 2 of 3 for (b)(4).
Additional Manufacturer Narrative
Product development investigation was completed.A visual inspection, device history record (dhr) review and drawing review were performed as part of this investigation.The 309.038 lot number 8083863 spare reamer tube was returned and reported to have broken during surgery, and the 309.510 lot number 2237232 conical extraction screw and 309.520 lot number 2242074 conical extraction screw were returned and reported as stripped.This condition is confirmed; approximately eleven millimeters of the distal end of the tube encompassing three teeth and roughly half the circumference has broken off and was not returned.Additionally, the conical extraction screws are broken along the distal threaded tip rather than stripped.It is likely that multiple years of use and possible rough handling during surgery or sterile processing has led to this complaint condition.The reamer tube was manufactured in 11/2012 and is over four years old.The 309.510 extraction screw was manufactured in 1/2007 and is over ten years old.The 309.520 extraction screw was manufactured in 2/2007 and is over ten years old.The balance of the returned devices is in fairly worn condition with some superficial wear.Relevant drawings were reviewed and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The condition of the returned devices does agree with the complaint description.Whether the complaint condition for these devices can be replicated is not applicable for this condition.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: CONICAL EXTRACTION SCREW FOR 1.5MM & 2.0MM CORTEX SCREWS
• Common Device Name: EXTRACTOR
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6393192
• Report Number: 9612488-2017-10105
• Device Sequence Number: 10873368
• Product Code: HWB
• UDI-Device Identifier: 10886982185815
• UDI-Public: (01)10886982185815(10)2237232
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 02/11/2017

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: 309.510
• Device Lot Number: 2237232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/11/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2017
• Supplement Report FDA Received Date: 04/07/2017
• 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: UNKNOWN PLATE, QUANTITY 1; UNKNOWN SCREWS, QUANTITY 1