MAUDE Adverse Event Report: AESCULAP AG TC WIRE HOLDING FORCEPS LAT-JAW 170MM; GENERAL SURGICAL INSTRUMENTS

Model Number LX176R

Device Problem Fracture (1260)

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

Event Date 03/08/2022

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 lx176r - tc wire holding forceps lat-jaw 170mm.According to the complaint description, the jaw was broken.During the removal of the forearm of a young girl, one of the two jaws has broke inside the arm: small pieces and several residues inside.The surgeon has removed all the residues with a dissecting forceps.An additional medical intervention was necessary.Additional information was not provided.Additional patient information is not available.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.Therefore, a thorough investigation is not possible.Batch history review due to the fact that neither an article number nor a lot number was provided, a review of the device history records must remain incomplete.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: based on the statement in the complaint, a third-party repair is to be assumed: after identification of the forceps by the pharmacists responsible for sterilization.We have found quotes for repair of the forceps jaws.As a result, the responsibility for handling this incident no longer rests with you.Please accept our apologies for the inconvenience and my delayed response due to a difficulty in identifying and providing a history of the forceps.The cancellation of this statement, which involved b.Braun, will be forwarded to ansm immediately.Conclusion and measures / preventive measures: based upon the investigation results, a maintenance-related root cause of the problem is most probable.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 investigations results a capa is not necessary.

• Brand Name: TC WIRE HOLDING FORCEPS LAT-JAW 170MM
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• 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: 13951430
• MDR Text Key: 288283775
• Report Number: 9610612-2022-00091
• Device Sequence Number: 1
• Product Code: HYA
• 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: 08/05/2022

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: LX176R
• Device Catalogue Number: LX176R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 07/11/2022
• Supplement Dates FDA Received: 08/05/2022
• 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
• Patient Sex: Female