MAUDE Adverse Event Report: AESCULAP AG TC BABY-CRILE-WOOD NDL HLDR SERR 150MM; DUROGRIP NEEDLEHOLDERS

Model Number BM013R

Device Problem Material Fragmentation (1261)

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

Event Date 06/17/2022

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 bm013r - tc baby-crile-wood ndl hldr serr 150mm.According to the complaint description, the piece broke off.A piece of the instrument fell into the belly of the patient.The piece was totally retrieved.An additional medical intervention was necessary.Additional information was not provided.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation: visual investigation: here we found a broken part off the carbide insert.Additionally, we detected brown discoloration and unknown deposits.Furthermore, we made a visual inspection of the fracture surface.No anomalies were discovered.Additionally, we could detect that the product was repaired by a third party.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5) according to din en iso 14971 is still acceptable.Explanation and rationale: investigations lead to the assumption that more than one indication could be the broken part of the carbide insert.It could be possible that reason for the broken part was caused by a third party repair.In addition, we could detected brown discoloration, which could be a sign of corrosion.Due to an existing pre-damage or weak point, the reprocessing could be breakage-triggering.There is the possibility for a pre-damage due to a mechanical overload situation or an excessive force.This could also be the cause for the broken off carbide insert.The exact cause could not be determined.Possibly an excessive force has been applied on the instrument or the possibility of high leverage with the instrument.Conclusion and measures / 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.Based upon the investigation results a capa is not necessary.

• Brand Name: TC BABY-CRILE-WOOD NDL HLDR SERR 150MM
• Type of Device: DUROGRIP NEEDLEHOLDERS
• 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 grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15052066
• MDR Text Key: 296140390
• Report Number: 9610612-2022-00196
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BM013R
• Device Catalogue Number: BM013R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 09/27/2022
• Supplement Dates FDA Received: 10/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention