MAUDE Adverse Event Report: SYNTHES BETTLACH HOLLOW REAMER COMPLETE FOR 3.5MM & 4.0MM SCREWS

Catalog Number	309.035
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.Implant and explant dates: device is an instrument and is not implanted/explanted.Initial reporter phone number: (b)(6).A device history record (dhr) review was performed for part # 309.035, lot # 2029755: manufacturing location: (b)(4), manufacturing date: 04.April 2002: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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 (b)(4) reports an event in (b)(6) as follows: it was reported that an extraction bolt and a reamer were damaged during an intervention on (b)(6) 2017.The thread of the reamer (309.035) is broken and there is a screw stuck inside the bolt (309.490), technician could not get the screw out.There was no impact on the patient and the patient is fine.The surgery was not prolonged.Concomitant device reported: screw (part # unknown, lot # unknown, quantity 1).This report is for one (1) hollow reamer complete for 3.5mm & 4.0mm screws.This is report 2 of 2 for complaint co (b)(4).
Additional Manufacturer Narrative
Returned to manufacturer.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 during an unknown procedure on (b)(6) 2017, and extraction bolt for 4.5mm screws broke and the thread of a hollow reamer complete for 3.5mm & 4.0mm screws is broken and has a screw stuck inside of it.Surgery was completed successfully with no delay.Concomitant devices reported: screw (part number unknown, lot number unknown, quantity 1).This report is for one (1) hollow reamer complete for 3.5mm & 4.0mm screws.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Customer quality conducted an investigation of the returned devices.Received parts: 1 x 309.490 / extract-bolt f/scr ø4.5+5 / lot no 9788362.1 x 309.035 / hollow-reamer-compl anticlockwise cutting / lot no 2029755.As received condition: 309.490: the part shows slightly scratches on surface.Furthermore we found a broken screwhead, stucked inside the inner-threaded hole of device.The broken part is missing.309.035: the surface shows slightly mechanical damages and the outside-thread is broken.The broken part is missing.Conclusion for 309.035: our investigation has shown that the surface has slightly mechanical damages and the outside-thread is broken.The broken part is missing.The manufacturing review for does show that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Unfortunately we only have limited information in the complaint description and cannot confirm how this happened.Because of the damage and without broken part the complaint relevant dimensions cannot be checked for dimensional accuracy.We do suppose that the cause of the breakage is the result of a mechanical overload situation during use.The microscopic view, with a magnification of 10x, of the broken surface shows a homogenous surface what indicates material conformity as well.Overall conclusion: based on the investigation results we conclude that the cause of failure is not due to any manufacturing non-conformances.Description clarification.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
Clarification of event: it is the extraction bolt that has a broken screw head stuck inside of it.The hollow reamer is broken.

• Brand Name: HOLLOW REAMER COMPLETE FOR 3.5MM & 4.0MM SCREWS
• Common Device Name: REAMER
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH254 4; SZ CH2544
• MDR Report Key: 6870514
• Report Number: 9612488-2017-10473
• Device Sequence Number: 636549
• Product Code: HTO
• UDI-Device Identifier: 07611819056497
• UDI-Public: (01)07611819056497(10)2029755
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2017

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: 309.035
• Device Lot Number: 2029755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 09/15/2017; 09/29/2017
• Initial Report FDA Received Date: 09/15/2017
• Supplement Report FDA Received Date: 09/25/2017; 10/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1