MAUDE Adverse Event Report: AESCULAP AG TC MATHIEU NDL HLDRSTDGRIP/RCHT200MM; DUROGRIP NEEDLEHOLDERS

Model Number	BM154R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a tc mathieu ndl hldrstdgrip/rcht200mm (part # bm154r) was used during a procedure performed on (b)(6) 2021.According to the complainant, the spring broke during surgery.The leaf spring of the mathieu needle holder was damaged during surgery.The damaged part may not be found and may remain in the patient's body.The patient's infection is unknown, but the sample has been disinfected.The complaint device has not been returned to the manufacturer for evaluation.The part possibly remained in the body.Although requested, additional information has not been made available.The adverse event is filed under (b)(4) reference (b)(4).
Additional Manufacturer Narrative
Update d9: product receipt date update h4: manufacturing date investigation results visual investigation the investigation was carried out visually and microscopically with the digital microscope and the digital camera panasonic.We carried out a visual investigation and determined a fracture of the spring at the fixing screw.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5) probability of occurrence1(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based on the fracture pattern with the corroded areas, we assume that the fracture was preceded by an incipient crack in the spring.This crack may have been caused by a mechanical overload situation.Moisture that was able to remain in the crack caused corrosion and ultimately led to the fracture.Based upon the investigations results a capa is not necessary.

• Brand Name: TC MATHIEU NDL HLDRSTDGRIP/RCHT200MM
• Common Device Name: 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: 12719757
• Report Number: 9610612-2021-00682
• Device Sequence Number: 12265543
• Product Code: HXK
• UDI-Device Identifier: 04038653028597
• UDI-Public: 4038653028597
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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
• Operator of Device: Health Professional
• Device Model Number: BM154R
• Device Catalogue Number: BM154R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown