MAUDE Adverse Event Report: LIMACORPORATE S.P.A BEATER - POSTIONER - ALIGNER

Model Number 9057.20.555

Device Problem Material Integrity Problem (2978)

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

Event Date 02/09/2016

Event Type  malfunction  

Manufacturer Narrative

No anomaly detected by checking the dhr of the lot # involved, on a total of (b)(4) acetabular cup inserter released on the market with the same lot #.No other complaint received on this lot #.We will submit a final report when the investigation will be completed.

Event Description

The screw thread of the alignment ring, of the acetabular cup impactor, was cross threaded.No impact on surgery and no reported consequences for the patient due to this issue.Event occurred in (b)(6).

• Brand Name: BEATER - POSTIONER - ALIGNER
• Type of Device: BEATER - POSTIONER - ALIGNER
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer (Section G): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, 33038 ; IT 33038
• Manufacturer Contact: giulio puppa
• MDR Report Key: 6688812
• MDR Text Key: 79388318
• Report Number: 3008021110-2016-00103
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K112158
• 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 Operator: Health Professional
• Device Model Number: 9057.20.555
• Device Lot Number: 201208032
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2017
• Date Device Manufactured: 07/23/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1