MAUDE Adverse Event Report: INTEGRA YORK, PA INC. RUGGLES GARDNER-WELLS TRACTION TONGS - STAINLESS; N/A

Catalog Number R1945

Device Problem Failure to Eject (4010)

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

Event Type  malfunction  

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

A facility reported that when used, the bar of the ruggles gardner-wells traction tongs - stainless (r1945) did not drop and caused the tongs to become stuck in the patients head.The tongs were so stuck in the patients head it took great force to unscrew the tongs and remove from the patients head.No adverse impact to the patient was reported, neither delay in surgery.

Manufacturer Narrative

The ruggles r1945 was returned for evaluation: failure analysis: the returned r1945 is in used condition with the pins stuck in position and unable to be adjusted by hand.Pin threading had damage due to rough handling/environmental damage, preventing proper adjustment.The retractor hook was disconnected from the unit.Root cause: the reported complaint is confirmed.The returned r1945 ruggles gardner-wells traction tongs is in used condition with the pins stuck in place due to damage to the threading.No manufacturing, workmanship, or material deficiency has been identified.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: RUGGLES GARDNER-WELLS TRACTION TONGS - STAINLESS
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA
• MDR Report Key: 11798351
• MDR Text Key: 252320133
• Report Number: 2523190-2021-00086
• Device Sequence Number: 1
• Product Code: HBG
• Combination Product (y/n): N
• PMA/PMN Number: K902818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: R1945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1