MAUDE Adverse Event Report: SYNTHES GMBH AIM-ARM RADIOLUC; NAIL, FIXATION, BONE

Catalog Number 03.043.029

Device Problem Material Integrity Problem (2978)

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

Event Date 11/08/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in germany as follows: it was reported that both the surgeon and the nurse assured the sales rep, that the target bar was correctly clicked in and that the damage only occurred when the nail was struck (the impact attachment was used).No patient harm.The surgery was successfully completed.This report is for one (1) aim-arm radioluc.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.D2b: additional product code: hwc.E1: (b)(6).H3, h4, h6: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that the device 03.043.029, aiming arm/ radiolucent 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 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.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the device 03.043.029, aiming arm/ radiolucent 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.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.Part:03.043.029, lot:2024223, manufacturing site: werk selzach, supplier: (b)(4), release to warehouse date:16 mar 2021, expiration date: na.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.

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 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 the aim-arm radioluc had both of the hooks of the latch broken.The broken fragments were not returned.Additionally the pin of the latch looks moved from his original position.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 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 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 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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.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

It was reported that there was a defective orthokit aiming arm on (b)(6) 2023.

• Brand Name: AIM-ARM RADIOLUC
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18321891
• MDR Text Key: 330467483
• Report Number: 8030965-2023-15670
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 07612334171108
• UDI-Public: (01)07612334171108
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Physician
• 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: 11/22/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 02/02/2024
• Supplement Dates FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - NAILS
• Patient Sex: Male