MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH GUIDE WIRE 3.2MM FOR PFNA BLADE

Catalog Number	356.83
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is an unknown date in (b)(6) 2019.Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/ or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(6) reports an event as follows: it was reported that during an unknown procedure in (b)(6) 2019, a guide wire of the proximal fixation nail anti-rotation (pfna) blade was drilled and broke.No fragments were created.Surgery was successfully completed with another guide wire.There was no patient harm.Concomitant devices: aiming arm (part: unknown, lot: unknown, quantity: unknown), insertion handle (part: unknown, lot: unknown, quantity: unknown), drill sleeve (part: unknown, lot: unknown, quantity: unknown), drill bit (part: unknown, lot: unknown, quantity: unknown), pfna nail (part: unknown, lot: unknown, quantity: unknown).This report is for a guide wire 3.2mm for pfna blade.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H3, h4, h6: device history lot part number: 356.83, lot number: 4l66753, manufacturing site: balsthal, release to warehouse date: 14.May 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: investigation summary, x-ray review: the received x-ray confirm the issue as per event description that the guide wire is damaged during drilling; the complaint therefore has been determined to be confirmed.Investigation site: (b)(4).Selected flow: damage.Visual inspection: the visual inspection of the guide wire ø 3.2mm, f/pfna blade has shown that 25mm above the thread tip is damaged (bored).At the guide wire shaft has of a length of 250mm some marks visible.The measured dimensions were found to be within the given specifications per the drawings referenced above.Drawing/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device.Summary: the complaint is rated as confirmed for this guide wire ø 3.2mm.Finally we are based on the provided information we are not able to determine the exact cause of this occurrence.We can only assume that there was a mechanical overload during the insertion process, which finally caused the post manufacturing damages.Multiple factors can lead to technical difficulties during insertion of guide wire.These factors could be: missing of a light hammer blow which hit the trocar into the bone to create an indentation in the bone which will help prevent the guide wire from skiving off the bone in the next step (angulation of the guide wire).If the guide is deformed during insertion use a new guide and discard the deformed guide wire.Furthermore we would like to draw your attention to our surgical technique of tfna which described the above mentioned points.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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: GUIDE WIRE 3.2MM FOR PFNA BLADE
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9575301
• Report Number: 8030965-2020-00232
• Device Sequence Number: 11488557
• Product Code: FZX
• UDI-Device Identifier: 07611819291355
• UDI-Public: (01)07611819291355
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2019

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: 356.83
• Device Lot Number: 4L66753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 12/13/2019
• Supplement Date Received by Manufacturer: 01/14/2020
• Initial Report FDA Received Date: 01/10/2020
• Supplement Report FDA Received Date: 02/07/2020
• 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: UNK - DRILL BITS: TRAUMA; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - NAIL INSERTION HANDLES; UNK - NAILS: PFNA