MAUDE Adverse Event Report: AESCULAP AG COLLECT.NO.QAS O/T INTERLOCKING NAILS

Model Number AE-QAS-O559

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Hypovolemic Shock (1917)

Event Date 09/08/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with the product ae-qas-o559 (unknown item code of interlocking nails).According to the complaint description, on (b)(6) 2020, the patient underwent nail removal surgery for a targon nail that had been placed in the right femur previously.During removal, the right superior gluteal artery and right lateral circumflex femoral artery were injured, resulting in hemorrhagic shock.The patient then died of multiple organ failure (date not specified).Statement from bbaj legal department: based on the information provided, we conclude that this was caused by the doctor injuring the arteries (right superior gluteal artery, right lateral circumflex femoral artery) during the nail removal surgery, and that this was not a case of malfunction of the medical equipment.Additional details were requested.The adverse event is filed under aag reference: (b)(4).

Manufacturer Narrative

Investigation results: as of the date of this report, the complaint product was not provided for investigation.We do not have any further information available at this time.A product investigation including the statistical analysis and a review of the device history record was not possible.Device history review: due to the fact that there is neither a product code nor a lot number, a review of the device history records for the complained device is not possible.According to manufacturer's reporting evaluation in accordance with 21 cfr 803, section 803.3, this event is considered reportable for the following reason: - serious injury (report not later than 30 days).The assessment for the reportability of this adverse event was based on patient harm, death.Conclusion/preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigation results, a capa is not necessary.

• Brand Name: COLLECT.NO.QAS O/T INTERLOCKING NAILS
• Type of Device: INTERLOCKING NAILS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 18351075
• MDR Text Key: 330812412
• Report Number: 9610612-2023-00272
• Device Sequence Number: 1
• Product Code: NDH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AE-QAS-O559
• Device Catalogue Number: AE-QAS-O559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Female