MAUDE Adverse Event Report: AESCULAP AG NEEDLE HOLDER SUPER RIGHTING 5MM/310MM; REUSABLE INSTRUMENTS

Model Number PL414R

Device Problem Break (1069)

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

Event Type  Injury  

Manufacturer Narrative

Investigation results: visual investigation: investigation was carried out visually.We detected a broken nose of the locking hook.This could be caused by a lack of lubrication on the sliding surface of the ratchet.Due to this lack of lubrication, friction was caused and finally this led to the breakage.The device requires regular lubrication as it involves metal on metal friction.Additives to machine cleaning processes by our experience have only limited lubrication effects, so we recommend the regular usage of special instrument oils to avoid such issues.Therefore, it is necessary to follow the point from the ifu ta011172 2021-09 change no.64.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.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) x probability of occurrence 1(5)) according to din en iso 14971 is still acceptable.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 upon the investigations results a capa is not necessary.

Event Description

It was reported that there was an issue with pl414r - needle holder super righting 5mm/310mm.According to the complaint description, the needle holder fragmented during surgery.A fragment was found inside the patients belly.An additional medical intervention was necessary.Additional information was not provided nor available.The adverse event is filed under (b)(4).

• Brand Name: NEEDLE HOLDER SUPER RIGHTING 5MM/310MM
• Type of Device: REUSABLE 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: 14468903
• MDR Text Key: 292357113
• Report Number: 9610612-2022-00139
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PL414R
• Device Catalogue Number: PL414R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention