MAUDE Adverse Event Report: AESCULAP AG TC TENOTOMY SCISSDELCVD1/SERR130MM; DENTAL

Model Number DO250R

Device Problem Fracture (1260)

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

Event Date 07/13/2022

Event Type  Injury  

Manufacturer Narrative

Investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported that there was an issue with do250r tc tenotomy scissdelcvd1/serr130mm.According to the complaint description, the scissor broke while cutting soft tissue.This occurred during a total shoulder replacement surgery.An additional medical intervention was required.An x-ray was taken intraoperatively; there was a delay of 10-15 minutes.Additional information was not provided.The adverse event is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.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.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.If the device is returned in the future, an investigation will again be completed at that time.Based upon the investigation results a capa is not necessary.

• Brand Name: TC TENOTOMY SCISSDELCVD1/SERR130MM
• Type of Device: DENTAL
• 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: 15214498
• MDR Text Key: 297764719
• Report Number: 9610612-2022-00208
• Device Sequence Number: 1
• Product Code: EGN
• UDI-Device Identifier: 04038653148301
• UDI-Public: 4038653148301
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/27/2022

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: DO250R
• Device Catalogue Number: DO250R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 08/11/2022
• Supplement Dates Manufacturer Received: 09/27/2022
• Supplement Dates FDA Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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