MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.2MM GUIDE WIRE 290MM; NAIL,FIXATION,BONE

Catalog Number	03.010.115
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 reports an event in (b)(6), as follows: it was reported on (b)(6), 2019, during decontamination process, a guidewire was found distorted or curved.There was no surgical procedure and patient involvement.This report is for one (1) 3.2 mm guide wire 290 mm.This is report 1 of 1 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 the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: a product investigation was conducted.Visual inspection: the device was found bent at the end of the shaft.Furthermore there are striation signs allover on the surface, thus the laser etching is only partially legible.The tip and it's thread are also damaged.The received condition agrees with the complaint description and the complaint was confirmed.Dimensional inspection: because no lot number was provided and the laser etching is not readable anymore the actual released drawing will be taken for the dimensional inspection.Feature: outer diameter (near bending point) was measured and is within specifications per relevant drawings.Document/ specification review: because no lot number was provided and the laser etching is not readable anymore due to the damage on the surface, a manufacturing review is not possible.Summary: the complaint condition is confirmed due to the condition of the returned device.It is likely that any unintended forces encountered by the device during use or handling could have contributed to the bent condition of guide wire.During the investigation, no product design or manufacturing issues or discrepancies were identified.By the evidence that the damages are caused post manufacturing, we can conclude that the cause of failure is not due to any manufacturing non-conformance's.Based on the investigation findings, 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: 3.2MM GUIDE WIRE 290MM
• Common Device Name: NAIL,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8775336
• Report Number: 8030965-2019-66114
• Device Sequence Number: 1999843
• Product Code: JDS
• UDI-Device Identifier: 07611819814950
• UDI-Public: (01)07611819814950
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K970097
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

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: 03.010.115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 08/21/2019
• Patient Sequence Number: 1