MAUDE Adverse Event Report: SYNTHES GMBH AIM-ARM 130° F/STAT+DYN DIST LOCK; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	03.037.113
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from depuy synthes reports an event in colombia as follows: it was reported that on (b)(6) 2023, surgeon manifests a poor calibration of the directional arm because, when measuring to place the spiral blade, it gives us a length of 105mm.This implant is passed and at the time of dismantling the screwdriver, a ¿cut out¿ of the blade of more than 20mm is evident.The dr requests change of the sheet of 105mm for one of 90mm.No negative impact on the patient.This report is for one (1) aim-arm 130° f/stat+dyn dist lock.This is report 1 of 2 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.
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: h3, h4, h6: part number: 03.037.113 lot number: 35p7561 manufacturing site: haegendorf release to warehouse date: 02.04.2020 a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo identified no visual defects on the aim-arm 130â° f/stat+dyn dist lock.Misalignment condition cannot be assessed through photo analysis.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for aim-arm 130â° f/stat+dyn dist lock.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.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.G1: manufacturing site name and address.
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.Date of concomitant therapy is (b)(6) 2023.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 the aim-arm 130â° f/stat+dyn dist lock that could have contributed to the misalignment issue reported.The tfna surgical technique guide was reviewed.Following relevant statements were found: instructions: choose the aiming arm that matches the angle of the nail inserted and securely attach to the insertion handle by tightening the thumb screw.Verify nail insertion depth and position for the helical blade/screw.Place a guide wire on the yellow marking of the aiming arm and radiographically check the guide wire position in ap.In the final position the yellow line on the guide sleeve is in alignment to the yellow line on the impactor.The helical blade must be fully inserted.Precautions: the distal tooth of the guide sleeve should rest on the lateral cortex.Do not overtighten on the cortex as this may affect the accuracy of the aiming assembly.Note: the measurement is calibrated from the tip of the guide wire to the tip of the tooth on the guide sleeve.With the available information provided, it is possible that the aiming system was not tightened accordingly or unintended forces were applied to the system; this may prevent accurate measuring.Additionally, the surgical technique recommends using image intensifying along the procedure to monitor measuring and positioning to ensure proper alignment of the nail head element.A dimensional inspection was performed for the aim-arm 130â° f/stat+dyn dist lock and met specifications.A functional test was unable to be performed as the mating devices from the system were not returned.The complaint condition was not able to be replicated.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 aim-arm 130â° f/stat+dyn dist lock 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.Drawing/specifications reviewed the following drawings reflecting the current and manufactured revisions were reviewed: aiming arm tfna 130° - asm - transverse dimensional inspection: measured dimensions: inner diameter of the guide sleeve insertion hole = conforming.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 130° 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 (CH); im bifang 6; haegendorf CO 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 17126931
• Report Number: 8030965-2023-07456
• Device Sequence Number: 15074899
• Product Code: HSB
• UDI-Device Identifier: 07611819642669
• UDI-Public: (01)07611819642669
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K131548
• 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: Physician
• Type of Report: Initial,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: 03.037.113
• Device Lot Number: 35P7561
• 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: 05/26/2023
• Supplement Date Received by Manufacturer: 07/13/2023; 08/09/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 07/28/2023; 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2020
• 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: UNK - NAIL HEAD ELEMENTS.; UNK - SCREWDRIVERS.
• Patient Sex: Unknown