MAUDE Adverse Event Report: SPIDER PLATE AND SCREWS; SPIDER LIMITED WRIST FUSION SYSTEM

Catalog Number XXX-SPIDER

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

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

It was reported the spider screw broke after implantation causing serious and permanent sequel and damage to the patient, loss of quality life and job.The initial surgery was on (b)(6) 2017.X-rays were provided showing that on (b)(6) 2017 the device was in good condition; x-ray from (b)(6) 2019 showed breakage of the screw and x-ray from (b)(6) 2019 was showing the broken part with more space.The breakage date is unknown.It is also unknown if another surgery was done.No additional information is available.

Manufacturer Narrative

Complaint sample was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

Manufacturer Narrative

Complaint sample was not returned for evaluation but x-ray images were provided.Evaluation of the x-rays showed that one (1) of the screws securing the implant was broken through the shaft of the screw.The failure was confirmed.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: SPIDER PLATE AND SCREWS
• Type of Device: SPIDER LIMITED WRIST FUSION SYSTEM
• MDR Report Key: 12485708
• MDR Text Key: 271871075
• Report Number: 1651501-2021-00041
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K991873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-SPIDER
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1