MAUDE Adverse Event Report: AESCULAP AG S4 ELEMENT LENKE PROBE CVD; INSTRUMENTS POSTERIOR STABILIS

Model Number FW249R

Device Problem Fracture (1260)

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

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to aesculap ag that a s4 element lenke probe cvd (part # fw249r) was used during a posterior lumbar interbody fusion ((plif) procedure performed on (b)(6)2021.According to the complainant, during use, the weld point at base of handle broke loose.The awl cracked but stayed together as one piece.The complaint device was returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation: visual investigation: we made a visual and microscopical investigation of the instrument, especially the broken weld seam.The weld seam shows no signs of a manufacturing error, the breakage occurred in the middle of the seam, which is a sign of a mechanical overload situation.In the next step we investigated the tip of the instrument.Here we found slight signs of wear and tear.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 weld seam shows no signs of a manufacturing error.The evaluation of the complaints over the last five years did not reveal any accumulations (this is the first instrument with such a defect pattern), so that process and design errors can 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 upon the investigation results a capa is not necessary.

• Brand Name: S4 ELEMENT LENKE PROBE CVD
• Type of Device: INSTRUMENTS POSTERIOR STABILIS
• 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: 12484998
• MDR Text Key: 272885518
• Report Number: 9610612-2021-00611
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 04046963743420
• UDI-Public: 4046963743420
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FW249R
• Device Catalogue Number: FW249R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2022
• 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