MAUDE Adverse Event Report: SYNTHES GMBH AIM-ARM 125 F/STAT+DYN DIST LOCK; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	03.037.114
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from japan reports an event as follows: it was reported that on (b)(6) 2022, the patient underwent the orif surgery for trochanteric fracture of femur.A guide wire for head elements seemed to interfere with the nail when the surgeon was inserting the guide wire using the insertion handle and aiming arm.The surgeon tried inserting the guide wire by pushing it a little stronger, then the guide wire got stuck and could not be removed.But the surgeon managed to remove the guide wire and tried to insert another new guide wire after checking the connection between the instruments and reversed the locking mechanism of the nail to reduce the risk of interference.The surgeon managed to succeed in inserting the guide wire.After that, the surgeon also had a difficulty in using a reamer with the insertion handle and aiming arm.Although the reamer went forward only a little, it still went forward to some extent, so the surgeon tried to insert a blade.However, even when the surgeon manually pushed the blade, it did not reach the nail, so the surgeon adjusted the operation by lifting the insertion handle a little and proceeded reaming again.The surgeon succeeded in reaming, and subsequent procedures were performed smoothly.The surgery was completed successfully within 30 minutes delay.No further information is available.This report is for an aim-arm 125 f/stat+dyn dist lock.This is report 3 of 3 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.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is a synthes employee.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 is not distributed in the united states, but is similar to device marketed in the usa.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.
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.H10 additional narrative: d4, e1, h4 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.
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.H3, h6: the subject device has been 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.
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.H3, h6: a product investigation was conducted.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects with theaim-arm 125â° f/stat+dyn dist lock.A dimensional inspection was performed for the insert-handle hybrid and met specifications.A functional test and the device assemble correctly.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the insert-handle hybrid was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H3, h6: a device history record (dhr) review was conducted: part: 03.037.114, lot no : 9705610, release to warehouse date: 05 jan 2016, manufacturing site: werk hagendorf.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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: AIM-ARM 125 F/STAT+DYN DIST LOCK
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 15322695
• Report Number: 8030965-2022-06136
• Device Sequence Number: 5203291
• Product Code: HSB
• UDI-Device Identifier: 07611819642676
• UDI-Public: (01)07611819642676
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

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: 03.037.114
• Device Lot Number: 9705610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 09/05/2022; 09/28/2022; 11/01/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 09/26/2022; 10/18/2022; 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INSERT-HANDLE HYBRID; TROCHANT FEM NAIL 10 125 L20; UNK - REAMERS: TRAUMA
• Patient Sex: Unknown