MAUDE Adverse Event Report: SYNTHES GMBH AIMING ARM RADIOLUCENT; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	03.233.006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2024
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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2024, the item was observed to be broken intra-operatively.The device was utilized with no adverse effects intra-operatively nor delays in the case.
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.H11 additional narrative: added: d9.H3, h6: the product was returned to j&j medtech orthopaedics for evaluation.¿visual inspection of the returned device revealed that the aiming arm radiolucent had both of the hooks of the latch broken.Fragments were not returned.No other issues were found.Therefore, the reported condition can be confirmed.A potential cause cannot be established with the provided information due to be a multifactorial issue.The semi-extended parapatellar approach surgical technique guide was reviewed.Following relevant statements were found.Precautions: -ensure that the connection between the nail and the insertion handle is tight.Retighten, if necessary, after hammering and prior to the attachment of the aiming arm.-do not attach the aiming arm to the insertion handle at this point.-do not exert forces on the aiming arm.These forces may prevent breakage of the device.Based on the investigation findings, the primary cause was related to the users hammering with the aiming arm in place or actually hitting on the aiming arm.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional evaluation was unable to be performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the aiming arm radiolucent would contribute to the complained device issue.Based on the investigation findings, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: part number: 03.233.006.Lot number: 124p989.Manufacturing site: haegendorf.Release to warehouse date: 14th may 2021.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.H11 additional narrative: added: d10.H3, h4, h6: the product was not returned to medtech orthopaedics, however photos were provided for review.During the analysis of the complaints two subcategories of the aiming arm (03.233.006) latch (60224287, drawing se_728332) failure were identified.The failure is a breakage of the carbon-fiber reinforced latch.The failure mode is an interlaminar breakage due to shear forces.Breakage is most likely favored by defects in the structure of the carbon fiber reinforced peek plate.It is in the nature of the material that the shear strength is highly anisotropic and lowest between carbon fiber layers.Likely interlaminar shear strength is reduced by defects resulting form manufacturing issues not leading to complete bond between the carbon layers.A dimensional inspection for the aim-arm radiolucent was not performed due to post manufacturing damage.As part of medtech orthopaedic quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition of the aim-arm radiolucent would contribute to the complained device issue.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review: part number: 03.233.006, lot number: 124p989, manufacturing site: haegendorf, release to warehouse date: 14th may 2021, a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: AIMING ARM RADIOLUCENT
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20396112
• Report Number: 8030965-2024-12600
• Device Sequence Number: 15455726
• Product Code: HSB
• UDI-Device Identifier: 10886982288363
• UDI-Public: (01)10886982288363(10)124P989
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• 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: 03.233.006
• Device Lot Number: 124P989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/17/2024; 10/23/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 10/17/2024; 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2021
• 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: AIMING ARM RADIOLUCENT
• Patient Sex: Unknown