MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - GUIDE/COMPRESSION/K-WIRES; NAIL, FIXATION, BONE

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Pma/510k: this report is for an unknown nail head element.Part and lot numbers are unknown; udi number is unknown.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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that intraoperatively during a pfna surgery on an unknown date, the surgeon had issues to lock the blade.He is complaining about the insertion handle (the insertion handle does not guide the guide wire sufficiently, the guide wire or blade ran out cranially).The blade has been looked freehanded.No consequence on the patient was reported.Concomitant device reported: unknown pfna nail (part# unknown; lot# unknown; quantity 1), unk - guides/sleeves/aiming: sleeve (part# unknown; lot# unknown; quantity 1), unk - insertion instruments: trocar: trauma unk - guides/sleeves/aiming: sleeve (part# unknown; lot# unknown; quantity 1), unk - nuts (part# unknown; lot# unknown; quantity 1), unk - impaction instruments: cmf (part# unknown; lot# unknown; quantity 1), unk - nail head elements: pfna blade (part# unknown; lot# unknown; quantity 1).This complaint involves three (3) devices.This is 3 of 3 for report (b)(4).

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.]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 Description

Updated concomitant device reported: unknown pfna nail (part# unknown; lot# unknown; quantity 1), aiming arm (part# 03.037.113; lot# 9770499; quantity 1), unk - insertion instruments: trocar: trauma unk - guides/sleeves/aiming: sleeve (part# unknown; lot# unknown; quantity 1), unk - nuts (part# unknown; lot# unknown; quantity 1), unk - impaction instruments: cmf (part# unknown; lot# unknown; quantity 1), unk - nail head elements: pfna blade (part# unknown; lot# unknown; quantity 1).

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 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: UNK - GUIDE/COMPRESSION/K-WIRES
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9342337
• MDR Text Key: 194632324
• Report Number: 8030965-2019-70377
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AIM-ARM 130° F/STAT+DYN DIST LOCK; UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - IMPACTION INSTRUMENTS: CMF; UNK - IMPACTION INSTRUMENTS: CMF; UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA; UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA; UNK - NAIL HEAD ELEMENTS: PFNA-II BLADE; UNK - NAIL HEAD ELEMENTS: PFNA-II BLADE; UNK - NUTS; UNK - NUTS; UNK - PFNA NAIL; UNK - PFNA NAIL