MAUDE Adverse Event Report: LIMACORPORATE S.P.A. SMR - REVERSE RESECTION JIG

Model Number 9013.52.304

Device Problems Bent (1059); Sticking (1597)

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

Event Type  malfunction  

Manufacturer Narrative

The check of the dhr of the lot # involved (lot #2014aa138) did not show any anomalies on the (b)(4) pieces manufactured with this lot#, thus indicating that the devices were compliant to specifications when they were released on the market.No other complaints reported on this lot#.We will submit a final mdr once our investigation will be concluded.

Event Description

Intra-operative issue: a lima pin got stuck and bent inside a smr reverse resection jig (code # (b)(4)).Event occurred on (b)(6) 2017.No reported consequences for the patient.Number of uses of the instrument unspecified.Event occurred in us.

• Brand Name: SMR - REVERSE RESECTION JIG
• Type of Device: SMR - REVERSE RESECTION JIG
• 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 ; IT
• MDR Report Key: 6753590
• MDR Text Key: 81572083
• Report Number: 3008021110-2017-00065
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100858
• 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: 07/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9013.52.304
• Device Lot Number: 2014AA138
• Was the Report Sent to FDA?: No
• 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