MAUDE Adverse Event Report: LDR MEDICAL SHIM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number EC020R

Device Problem Fracture (1260)

Patient Problems Muscle Weakness (1967); Nerve Damage (1979); Foreign Body In Patient (2687); Nervous System Injury (2689); No Code Available (3191)

Event Date 07/20/2015

Event Type  Injury  

Manufacturer Narrative

The shims were visually inspected, the inspection of the returned shims confirms that two of the three have the middle tabs broken off.Likely cause for the event is due to user error.The investigation found no evidence to indicate a device issue.Review of inspection records found lot compliant.

Event Description

It was reported that during the procedure an avenue retractor shim was bent and straightened by the surgeon, and then broke when the trial hit it.A section of the device was retained by the patient.Three days postoperatively, the patient was reported to have developed neuropxia, calf and thigh numbness, and quad weakness that was attributed to the retained device.It was also reported that since that time, the patient has undergone four additional surgeries related to the injury.

• Brand Name: SHIM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): LDR MEDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer (Section G): LDR MEDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: florence maily ; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300 ; 33382803
• MDR Report Key: 10450070
• MDR Text Key: 204347083
• Report Number: 3004788213-2020-00122
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC020R
• Device Lot Number: 410157814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Weight: 41