MAUDE Adverse Event Report: SYNTHES GMBH AIMING ARM/ RADIOLUCENT; NAIL, FIXATION, BONE

Catalog Number 03.043.029

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2023

Event Type  malfunction  

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.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.E3: reporter is a j&j sales representative.H3, h4, h6: device history record (dhr) review conducted: product code: : 03.043.029.Lot number : 2024223.Release to warehouse date : 16.Mar.2021 expiration date : na.Supplier: (b)(6).Manufacturing site: werk selzach.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.H6: photo investigation: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that aim-arm radioluc had both of the hooks of the latch broken.The device shows the signs of usage and broken hooks of latch and no evidence of hammer marks were observed, therefore, a potential cause cannot be established with the provided information.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.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the aim-arm radioluc would contribute to the complained device issue.Based on the investigation findings, potential cause not established 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 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 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 depuy synthes reports an event in australia as follows: it was reported that on december 29, 2023, during the loan kit inspection it was identified by loan kit technician that the tabs of the device is broken.There is no surgeon, procedure, or patient details available.No further information can be obtained.This report is for one (1) aiming arm/ radiolucent this is report 1 of 1 for complaint (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.H3,h4,h6 the device associated with this report was returned to depuy synthes for evaluation.Visual analysis of the returned sample revealed that both tabs of the device are broken apart.The device has signs of normal use/wear and no evidence of hammer marks were observed, therefore, a potential cause cannot be established with the provided information.The semi-extended parapatellar approach surgical technique guide se_814687 ad 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.A dimensional inspection for the aim-arm radioluc was not performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the aim-arm radioluc would contribute to the complained device issue.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Drawing/specifications reviewed the following source controlled drawings reflecting the current and manufactured revisions were reviewed: dgw se_727957 rev.I (current) / rev.H (manufactured) latch se_728332 rev.G (current ) / rev.F (manufactured) dimensional inspection: n/a.H4,h6 part: 03.043.029, lot: 2024223, release to warehouse date: 16 mar 2021, manufacturing site: werk selzach, supplier: (b)(4).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: AIMING ARM/ RADIOLUCENT
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 18528151
• MDR Text Key: 333374312
• Report Number: 8030965-2024-00977
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 07612334171108
• UDI-Public: (01)07612334171108
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K201336
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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
• Device Operator: Health Professional
• Device Catalogue Number: 03.043.029
• Device Lot Number: 2024223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 03/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1