MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD LEKSELL RONG 9 SLIGHT-CVD 8MM; N/A

Model Number	230261
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the doctor was using the leksell rong 9 slight-cvd 8mm (230261) "inside patient when one side of bite broke off.A small piece of metal was recovered but doesn't look like the full piece that broke off.Checked all raytec for any additional metal, none found, had xray take pictures and sent to radiology to see if any metal can be found and confirmed with cell saver that if piece of metal was sucked up that it would be stopped at filter when blood was spun down.Or manager called into room, and instrument and piece of metal taken to risk management by or manager." it was reported that not all broken parts were recovered; only a small fragment was recovered.Per staff, no additional fragments were found in raytec and no fragments were visible via x-ray.X-ray findings determined operative changes following lumbosacral fusion without unexpected findings.The patient was transferred to the recovery room in stable condition, with no detectable harm resulting from the incident.The patient was discharged from the hospital on (b)(6) 2022, with no known procedural complications.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The leksell rong 9 slight-cvd 8mm (230261) was returned for evaluation.Device history record (dhr) was reviewed and no anomalies that could be associated with the complaint were observed.The leksell rong was received in used condition with the tip of one of the jaws broken due to rough handling/environmental damage.The product lot number indicates a manufacture date of 2013.The breakage may have been the result of damage over time.The reported complaint was confirmed.No manufacturing, workmanship or material deficiency has been identified.

• Brand Name: LEKSELL RONG 9 SLIGHT-CVD 8MM
• Common Device Name: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 16078867
• Report Number: 3014334038-2022-00288
• Device Sequence Number: 6639857
• Product Code: HTX
• UDI-Device Identifier: 10381780382775
• UDI-Public: 10381780382775
• Combination Product (Y/N): N
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: 230261
• Device Catalogue Number: 230261
• Device Lot Number: 56-1302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 12/30/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2013
• 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