MAUDE Adverse Event Report: LIMACORPORATE SPA MODULUS-STRUM. - ESTRATTORE CO; MODULUS-STRUM. - ESTRATTORE CO (JDI,KWY,KWZ,LPH)

Model Number 9043.10.360

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/04/2019

Event Type  malfunction  

Manufacturer Narrative

By checking the manufacturing chart of the lot #1213994, no anomaly was found.This is the first and only complaint received with this lot number.We will submit a final mdr once the investigation will be completed.

Event Description

Intra-operative issue happened on the (b)(6) 2019.During surgery, the surgeon was trying to detach only the femoral neck to adjust neck angle, but the neck cannot be detached from the stem resulting in breakage of the neck extractor code 9043.10.360 lot #1213994.Eventually, the surgeon explanted both the neck and the stem.The event prolonged the surgery of three hours.Event occurred in (b)(6).

• Brand Name: MODULUS-STRUM. - ESTRATTORE CO
• Type of Device: MODULUS-STRUM. - ESTRATTORE CO (JDI,KWY,KWZ,LPH)
• Manufacturer (Section D): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE SPA; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: federica malvaso ; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• MDR Report Key: 8801853
• MDR Text Key: 200422086
• Report Number: 3008021110-2019-00083
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• PMA/PMN Number: K112158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 07/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 9043.10.360
• Device Lot Number: 1213994
• Date Manufacturer Received: 07/11/2019
• 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