MAUDE Adverse Event Report: LIMACORPORATE SPA PINS EXTRACTOR

Model Number 9066.35.625

Device Problem Difficult to Remove (1528)

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

Event Date 05/03/2022

Event Type  malfunction  

Manufacturer Narrative

By the check of the device history records of the component involved, no pre-existing anomaly was detected on the instruments that belong to the same lot number (20ag0uj).This is the first and only complaint received on this lot number.We will submit a final report after the conclusion of the investigations.

Event Description

Intra-operative issue occurred during knee surgery on (b)(6) 2022 with the pins extractor code (b)(4), lot 20ag0uj: difficulty to extract the pin.According to the information received, during the same surgery 2 additional incidents occurred, which were reported to the competent authority as complaint (b)(4) (3008021110-2022-00041) and (b)(4) (3008021110-2022-00040).Due to these issues, there was a delay of about 20/25 minutes to complete the surgery.This incident occurred in italy.

• Brand Name: PINS EXTRACTOR
• Type of Device: PINS EXTRACTOR
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele; udine, 33038 ; IT 33038
• MDR Report Key: 14460627
• MDR Text Key: 300342212
• Report Number: 3008021110-2022-00042
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9066.35.625
• Device Catalogue Number: 9066.35.625
• Device Lot Number: 20AG0UJ
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization