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

Model Number BM077R

Device Problem Material Fragmentation (1261)

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

Event Date 02/14/2022

Event Type  Injury  

Event 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).

Manufacturer Narrative

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

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
• 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: 13810384
• MDR Text Key: 288619049
• Report Number: 9610612-2022-00086
• Device Sequence Number: 1
• Product Code: HXK
• UDI-Device Identifier: 04038653028337
• UDI-Public: 4038653028337
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/13/2022
• 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