MAUDE Adverse Event Report: AESCULAP AG TC HEGAR NEEDLE HOLDER HVY-SERR 205MM; DUROGRIP NEEDLEHOLDERS

Model Number	BM077R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap (b)(4) that a tc hegar needle holder hvy-serr 205mm (part # bm077r) was used during a procedure performed on (b)(6) 2022.According to the complainant, the part of the tungsten carbide inlay on the tip of the jaw detached and remained in the patient.This was noticed following surgery and the patient was returned to surgery to have the piece removed.The complaint device was returned to the manufacturer for evaluation.A revision surgery was necessary.However, the surgical sales specialist explained that the reporter stated no patient harm.Although requested, additional information has not been made available.The adverse event is filed under aesculap (b)(4) reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Investigation: the investigation was carried out visually and microscopically.We carried out a microscopical investigation and determined that one carbide insert was broken off in the middle.To allow surface reworking, the labeling of the needle holder was taped off.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 1(5)) according to din en iso 14971 is still acceptable.Explanation and rationale: the carbide insert was broken due to a mechanical overload situation.The lettering was taped off to finish the remaining surface of the instrument.This is a clear indication of a third-party repair, which is not allowed.A connection between the breakage an the third-party repair cannot be ruled out.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 on the investigation results, a capa was not required.

• Brand Name: TC HEGAR NEEDLE HOLDER HVY-SERR 205MM
• 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: 13810384
• Report Number: 9610612-2022-00086
• Device Sequence Number: 2150164
• Product Code: HXK
• UDI-Device Identifier: 04038653028337
• UDI-Public: 4038653028337
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2022

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
• Operator of Device: Health Professional
• Device Model Number: BM077R
• Device Catalogue Number: BM077R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 04/13/2022
• Initial Report FDA Received Date: 03/18/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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