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

Model Number L-621000

Device Problem Naturally Worn (2988)

Patient Problem Limb Fracture (4518)

Event Date 03/13/2023

Event Type  Injury  

Manufacturer Narrative

Product had been in use for 1 year when complaint was filed due to lock/release failure.User fell and sustained a broken elbow.The locking plate and locking pin were found worn so pin would release from lock without pressing the release mechanism when not fully engaged.Product wear is a known disadvantage with ratchet lock where unhardened guide plate and hardness differences between locking pin and locking plate may have been more susceptible to a binding effect between similar stainless-steel material and subsequent faster wear down.Capa is in progress to address issues with premature wear of the lock.User had had issues with pin coming loose 4 times in the days prior to injury.Instructions for use for the device includes a warning that if there is change in or loss in device functionality, the user should stop using the device and contact a healthcare professional.The majority of complaints regarding this issue were not associated with an incident, but discovered in a timely manner.

Event Description

The patient was walking to work, and the prosthesis came off and he fell.He was injured, suffering bruising to the stump and a fractured elbow.

• Brand Name: ICELOCK 621 RATCHET
• Type of Device: PROSTHETIC LOCK
• Manufacturer (Section D): OSSUR MEXICO; blvd. hector teran teran 2102; build #1 col canon del padre; tijuana, baja california 22206 ; MX 22206
• Manufacturer Contact: katla axelsdottir ; grjothals 1-5; reykjavik, 110 ; IC 110
• MDR Report Key: 16680633
• MDR Text Key: 312674311
• Report Number: 3008523132-2023-00002
• 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
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• 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 Lot Number: MX211022
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other