MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH INNER SHAFT FOR EXTRACTION SCREWDRIVER; SCREWDRIVERS

Catalog Number	03.613.004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is not available for reporting.Date of event is reported as (b)(6) 2018; exact date is unknown.Device is an instrument and is not implanted/explanted.Reporter phone number is not provided for reporting.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.A review of the device history records has been requested and is currently pending completion.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 an unknown surgery performed on an unknown date, the inner shaft for extraction screwdriver broke.The broken fragment was retrieved easily and was not left in the patient.Surgery was completed successfully with no surgical delay and no patient harm.This is report 1 of 1 for complaint (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 the potential event described in this report.Device evaluated by mfr: part # 03.613.004; synthes lot # 7706957; supplier lot # 7706957; release to warehouse date: july 31, 2014; supplier: (b)(4); no nonconformance reports (ncr's) were generated during production.Review of the device history record(s) (dhr) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.The evaluation of the inner shaft of the extraction screwdriver has shown that the threaded tip is broken off as complained.The broken off portion was not returned.The shaft is in a used condition and is bent.The ø 2.0 close to the breakage of the inner shaft got measured.Diameter: d = ø2.0 +0.02/-0.02 mm; caliper: 3-01-17584; measured drill bit diameter = ø 2.00 mm.Conclusion: the measuring result does show conformity.The instrument was analyzed for conformance to print specifications, as well as the device history records were researched.No abnormal findings were identified.The broken surface is homogenous which indicates material conformity to the specification as well.There were no details about the event provided, which makes it impossible to define an exact root cause.We only can assume that a short time overloading (torsional stress) associated with an unintended bending moment led to the breakage.Based on these findings we conclude that the cause of failure is not due to any manufacturing non-conformances.It has been determined that no corrective and/or preventative action is proposed.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: INNER SHAFT FOR EXTRACTION SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7385101
• Report Number: 8030965-2018-52608
• Device Sequence Number: 13704945
• Product Code: HXX
• UDI-Device Identifier: 07611819325906
• UDI-Public: (01)07611819325906(10)7706957
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2018

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: 03.613.004
• Device Lot Number: 7706957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 03/30/2018
• Supplement Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1