MAUDE Adverse Event Report: OSSUR HF ICELOCK 621 RATCHET; PROSTHETIC LOCK

Model Number L-621000

Device Problems Detachment of Device or Device Component (2907); Naturally Worn (2988)

Patient Problem Limb Fracture (4518)

Event Date 11/24/2022

Event Type  Injury  

Event Description

Patient was walking when the pin released from the lock in the prosthetic socket and patient lifted out of the socket.The patient suffered a broken wrist.

Event Description

Patient was walking when the pin released from the lock in the prosthetic socket and patient lifted out of the socket.The patient suffered a broken wrist.

Manufacturer Narrative

Lock failed to provide secure suspension resulting in user falling sustaining fractured scaphoid.Product had been in use for 1 year.The locking plate was found worn but pin was not returned.Lock having been used with already worn pin has been identified as likely root cause of failure as it may lead to early breakdown of the locking plate.

• Brand Name: ICELOCK 621 RATCHET
• Type of Device: PROSTHETIC LOCK
• Manufacturer (Section D): OSSUR HF; grjothals 1-5; reykjavik, 110 ; IC 110
• Manufacturer Contact: katla axelsdottir ; grjothals 1-5; reykjavik, 110 ; IC 110
• MDR Report Key: 16205836
• MDR Text Key: 307700332
• Report Number: 3003764610-2023-00003
• Device Sequence Number: 1
• Product Code: ISH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: L-621000
• Device Catalogue Number: L-621000
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other