MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA COMPRESSION BALL; N/A

Catalog Number 443A1067

Device Problem Crack (1135)

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

Event Type  malfunction  

Event Description

This is 3 of 3 reports for part #443a1067, linked to mfg report numbers: 3004608878-2022-00158, 3004608878-2022-00159.A facility reported that there was a crack in the area where the compress ball (443a1067) is placed in the radiolucent halo ring system.The incident occurred during the first surgery itself as the whole system had never been used.The medical staff had to change the entire radiolucent mayfield system to standard mayfield system and use the standard budde halo for the surgery.There was no patient injury since it was not used on the patient; however, this led to increased surgery time of 90 minutes.

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 Description

N/a.

Manufacturer Narrative

The radiolucent budde halo retractor system (a1096) was returned for evaluation: device history record (dhr): the dhr was reviewed and shows no abnormalities related to the reported failure.Failure analysis - inspection of the returned budde halo system confirms the reported complaint.There was a small crack in the threads where the compression ball is placed.Root cause - probable root cause is physical damage from rough handling of the unit.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

Manufacturer Narrative

Corrected fields: h6 (type of investigation, investigation findings, investigation conclusion).

Event Description

N/a.

• Brand Name: COMPRESSION BALL
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15176117
• MDR Text Key: 304996899
• Report Number: 3004608878-2022-00160
• Device Sequence Number: 1
• Product Code: GZT
• Combination Product (y/n): N
• PMA/PMN Number: K830332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 443A1067
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2022
• 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