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

Model Number	FW249R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
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 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).
Additional 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
• Common Device Name: 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
• Report Number: 9610612-2021-00611
• Device Sequence Number: 14460881
• Product Code: HXB
• UDI-Device Identifier: 04046963743420
• UDI-Public: 4046963743420
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Supplement Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 10/29/2022
• 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
• Patient Sex: Unknown