MAUDE Adverse Event Report: LIMACORPORATE S.P.A. PHYSICA - FEMORAL PEGS DRILL; PHYSICA - INSTRUMENTS - FEMORAL PEGS DRILL

Model Number 9065.10.800

Device Problem Material Integrity Problem (2978)

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

Event Date 10/17/2022

Event Type  malfunction  

Manufacturer Narrative

By the check of the device history records, no pre-existing anomaly was detected on the overall drill belonging to lot number 15ab17c.First complaint received on this specific lot number.We will send a final mdr once the investigation will be completed.

Event Description

Intra-operative breakage of physica - femoral pegs drill, product code 9065.10.800, lot 15ab17c experienced on (b)(6) 2022.According to the complaint source, the drill broke while using it during a physica kr procedure (knee replacement surgery).Due to this issue, another instrument was used to complete successfully the surgery with no delay nor consequences for the patient.Exact number of uses of the instrument is unknown but according to the complaint source, the instrument was used regularly.Event happened in us.

Event Description

Intra-operative breakage of physica - femoral pegs drill, product code 9065.10.800, lot 15ab17c experienced on (b)(6) 2022.According to the complaint source, the drill broke while using it during a physica kr procedure (knee replacement surgery).Due to this issue, another instrument was used to successfully complete the surgery with no delay nor consequences for the patient.Exact number of uses of the instrument is unknown but according to the complaint source, the instrument was used regularly.Event happened in united states.

Manufacturer Narrative

Investigation: by the check of the device history records, no pre-existing anomaly was detected on the overall drill belonging to lot number 15ab17c.This is the first complaint received on this specific lot number.Analysis of the instrument: the instrument was available to be returned for further inspection.Firstly, a dimensional check of the instrument has been performed, without finding any anomaly (the instrument is in compliance with the drawings).By a visual check of the tip broken, it is probable that the instrument has been forced during the surgery, and this caused the breakage of the tip: in particular, if an axial strength is applied on the instrument, this condition could lead to the bending of the tip.Therefore, considering that: by checking the device history record, no pre-existing anomaly was found on the pieces belonging to the lot number involved in the complaint.The most likely cause of the breakage is an axial strength applied on the instrument during its use.We can conclude that the event was not product related.Pms data: according to the relevant pms data, the breakage rate of the physica - femoral pegs drill, product code 9065.10.800, is around 0,09%.Please note that this occurrence rate is overestimated because it does not consider the reuse of the instruments but only the total number of pieces manufactured.No corrective actions are required for this specific case.Limacorporate will continue monitoring the market to promptly detect any further similar issue.This is a final mdr.

• Brand Name: PHYSICA - FEMORAL PEGS DRILL
• Type of Device: PHYSICA - INSTRUMENTS - FEMORAL PEGS DRILL
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 15780418
• MDR Text Key: 307087769
• Report Number: 3008021110-2022-00108
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• PMA/PMN Number: K141934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9065.10.800
• Device Lot Number: 15AB17C
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization