MAUDE Adverse Event Report: AESCULAP AG CASPAR DISTR PIN16MMSTER; SPINE SURGERY

Model Number FF905SB

Device Problem Material Fragmentation (1261)

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

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported to aesculap inc.That a caspar distr pin16mmster (part # ff905sb) was used during an anterior cervical fusion procedure performed on (b)(6) 2022.According to the complainant, the product "failed." reportedly, the device broke and pieces detached into the patient.The pieces were retrieved, and then the procedure was able to be continued and successfully completed without any further issues.The complaint device has not been returned to the manufacturer for evaluation.An additional medical intervention was required; broken pieces were retrieved.There was no surgical delay.Although requested, additional information has not been provided.The adverse event / malfunction is filed under aic reference (b)(4).

Manufacturer Narrative

Investigation results: there are no products available, therefore an investigation is not possible.Insufficient information and material to investigate.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.Root cause cannot be finally concluded.Therefore the root cause specific risk cannot be identified.The potential risk determined during initial vigilance evaluation remains valid.Explanation and rationale: without the product, an exact cause cannot be determined at this moment.Due to the constant monitoring of the compliance with our quality standards, as matters stand, a production or material defect can most likely be excluded.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.

• Brand Name: CASPAR DISTR PIN16MMSTER
• Type of Device: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 15212190
• MDR Text Key: 297762560
• Report Number: 2916714-2022-00086
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 04038653364329
• UDI-Public: 4038653364329
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2022,05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FF905SB
• Device Catalogue Number: FF905SB
• Device Lot Number: 52552420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2022
• Distributor Facility Aware Date: 07/13/2022
• Device Age: 33 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male