MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.2MM THREE-FLUTED DRILL BIT QC/210MM/68MM CALIBRATION; BIT,DRILL

Catalog Number	315.330
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient involvement was reported.Device is an instrument and is not implanted/explanted.Date returned to manufacturer.Initial reporter telephone: (b)(6).Initial reporter is synthes affiliate.Subject device has been received and is currently in the evaluation process.(b)(4) no code available used to capture no patient involvement.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 that during inspection of the devices, it was noted the 3.2mm three-fluted drill bit is broken.No patient involvement was reported.This is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to dhr review was completed.Part number: 315.330 synthes lot number: 8781855 release to warehouse date: 13.Jan.2014 manufacturing site: bettlach no 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.H3, h6: customer quality conducted an we have received a drill bit for investigation.The visual inspection has shown that approximately 7mm from the fluted tip section is broken off.The broken tip was not returned for evaluation.Further investigation has shown that the three blades are worn and the shaft (area after the blades) / connection part are signs of wear and tear.The device history record was researched, no abnormal findings were identified.There were no issues during the manufacturing of the product that would contribute to this complaint condition.The measurements of the hardness after the hardening procedure were between 53.8 ¿ 54.5 hrc also within the specification of 52 +3/0 hrc.The used material was stainless steel 440 a as required.This lot of 119 pieces was manufactured in january 2014 according to our specification.Based on these findings we exclude any manufacturing related issue.Based on the provided information we are not able to determine the exact cause which has led to this breakage.We only can assume that a mechanical overloading situation, for example metallic contact or lateral stress, has caused the breakage.Measurement outer diameter ø3.2: gage: 3-01-19788 tolerance ø 3.2 0/-0.03 result: ø3.17 "pass" based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Dhr review, no issue.Initial medwatch reported date of event as (b)(6) 2018.It is not known when the device broke.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: 3.2MM THREE-FLUTED DRILL BIT QC/210MM/68MM CALIBRATION
• Common Device Name: BIT,DRILL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7304955
• Report Number: 8030965-2018-51552
• Device Sequence Number: 1328365
• Product Code: HTW
• UDI-Device Identifier: 07611819020184
• UDI-Public: (01)07611819020184(10)8781855
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2018

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: 315.330
• Device Lot Number: 8781855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Initial Date Received by Manufacturer: 02/02/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1