MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SCREW,POLYAXLOCKING,MINI T8,2.4X8MM

Catalog Number MMSL2408

Device Problem Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/09/2022

Event Type  Injury  

Manufacturer Narrative

According to the customer contact, on (b)(6) 2022 it was reported that a screw broke while engaging with the plate.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable to provide further incident details to the manufacturer.The sample is not available to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

Screws broke while engaging with the plate.

• Type of Device: SCREW,POLYAXLOCKING,MINI T8,2.4X8MM
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16096713
• MDR Text Key: 306637123
• Report Number: 1417592-2023-00014
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: MMSL2408
• Device Lot Number: 810304
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: R-22-199
• Patient Sequence Number: 1
• Patient Outcome(s): Other