MAUDE Adverse Event Report: LIMACORPORATE S.P.A. ANATOMIC RESECTION JIG; KWT, HSD

Model Number 9013.50.304

Device Problem Temperature Problem (3022)

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

Event Type  malfunction  

Manufacturer Narrative

The check of the dhr of the lot # of resection jig involved (2014aa268) did not show any pre-existing anomaly on the 62 resection jigs manufactured with this lot #.No other complaint was received on this lot #.Model # and lot # of the pin involved are not available at the moment.We will receive the pieces involved (resection jig + pin) and submit a final mdr after analyzing them.

Event Description

Intra-operative issue: a pin got cold welded into one of the holes of the smr anatomic resection jig.Surgical time prolonged of 2 minutes.No consequences for the patient were reported.Event occurred in (b)(6).

• Brand Name: ANATOMIC RESECTION JIG
• Type of Device: KWT, HSD
• Manufacturer (Section D): LIMACORPORATE S.P.A.; IT
• Manufacturer (Section G): LIMACORPORATE S.P.A.; IT
• Manufacturer Contact: giulio puppa ; IT
• MDR Report Key: 5740999
• MDR Text Key: 48837781
• Report Number: 3008021110-2016-00028
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K100858
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• 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: 9013.50.304
• Device Lot Number: 2014AA268
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2014
• 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