MAUDE Adverse Event Report: LIMACORPORATE SPA UNIVERSAL PIN IMPACTOR

Model Number 9065.20.111

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 05/03/2022

Event Type  malfunction  

Event Description

Intra-operative issue occurred during knee surgery on (b)(6) 2022 with the universal pin impactor code 906520111, lot 20ah01p: lack of pin retention.According to the information received, during the same surgery 2 additional incidents occured, which were reported to the competent authority as complaint (b)(4) (3008021110-2022-00040) and (b)(4) (3008021110-2022-00042).Due to these issues, there was a delay of about 20/25 minutes to complete the surgery.Event occurred in italy.

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 (20ah01p).This is the first and only complaint received on this lot number.We will submit a final report after the conclusion of the investigations.

• Brand Name: UNIVERSAL PIN IMPACTOR
• Type of Device: UNIVERSAL PIN IMPACTOR
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 14453871
• MDR Text Key: 300379559
• Report Number: 3008021110-2022-00041
• Device Sequence Number: 1
• Product Code: LXH
• 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

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9065.20.111
• Device Catalogue Number: 9065.20.111
• Device Lot Number: 20AH01P
• 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