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

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	01/10/2023
Type of Reportable Event	Malfunction
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.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Device is not distributed in the united states, but is similar to device marketed in the usa.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 synthes reports an event in colombia as follows: it was reported on (b)(6) 2023 that during surgery, the triple set of sheath, guide, and trocar is used for spiral blade placement.The guide of 3.2 is passed, it is measured, it passes the side cortical drill which is with evident wear on its edges and proceeded to pass the spiral blade through the sheath.The impactor does not enter the sheath well and the specialist has to hammer hard to be able to enter and pass the blade through the sheath and then over the bone.When removing the device to perform the distal lock on the directional arm since it is a short nail, it is not possible to remove it, the impactor did not come out and the specialist manages to remove it from the sheath with hammer blows.Subsequently the sheath and compression support nut are locked in the directional arm and cannot be removed.Several maneuvers are attempted to remove the sheath but this is not possible.In one of these maneuvers, the proximal part of the 4.2 long drill bit is broken.After trying without results, the entire arm is removed, the doctor decides to perform distal block by freehand, where the tip of the short drill bit of 4.2 splits, being left inside the patient.Additionally, another doctor enters the operating room and the specialist tells him about the situation, he puts on sterile gloves and manipulates the directional arm and the sheath trying to remove it to perform the distal block, hammers the sheath at the tip part and the sheath bends.The doctor is respectfully told not do that, that he will end up further damaging the equipment and the doctor retreated to one side and left the instruments.The specialist, despite what happened, manages calmly during the surgery but leaves in evidence the annoyance for the failures of the equipment, recognizing that it was mistake of the equipment, not human, since he knows the instruments and has already placed the nail on several occasions.This report is for one (1) aim-arm 130â° f/stat+dyn dist lock.This is report 1 of 4 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.Eight (8) photographs were returned to depuy synthes for evaluation.Visual analysis of the photographs found that the photograph on page 4 showed the guide sleeve, buttress/compression nut and aiming arm assembled.The photograph on page 5 shows the top of the guide sleeve on the insertion end.No damage or issue is visible in the photographs on page 4 or 5.The photograph on page 8 shows significant damage on the distal end of the guide sleeve that would contact the lateral cortex.The end of the guide sleeve is flattened, the edge is rolled over and the bottom edge is bent inward.This is consistent with the end of the guide sleeve being impacted by another instrument.Based on the reported condition noting the 3 instruments could not be separated, the damage is most likely from attempts to separate the instruments using a hammer.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection could not be completed.A document/specification review was not completed as it was not related to the reported issue.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for aiming arm as the damage noted on the guide sleeve would indicate significant attempts to separate the instruments.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.
Event or Problem Description
This is report 1 of 6 for complaint.
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: d10.Therapy dates: (b)(6) 2023.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.B5-this is report 1 of 6 for complaint.

• Brand Name: AIM-ARM 130° F/STAT+DYN DIST LOCK
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16286482
• Report Number: 8030965-2023-01325
• Device Sequence Number: 20529560
• 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: Other Health Care Professional
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 02/23/2023; 08/09/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 03/14/2023; 08/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BUTTRESS/COMPR-NUT; DRILL BIT F/LATERAL CORTEX OPENING F/QUI; DRILL BIT Ø4.2 CALIBR L145 3FLUTE F/QUIC; DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/QUIC; GUIDE SLEEVE YELL; TFNA HELICAL-BLADE IMPACT
• Patient Sex: Unknown