MAUDE Adverse Event Report: LIMACORPORATE S.P.A. MANUAL SNAP WRENCH

Model Number 9095.10.110

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

By checkng the dhr of the instrument involved, no pre-existing anomaly was found on the 31 instruments belonging to the same lot# (11h5257).First and only complaint received on this lot#.We will submit a final mdr as soon as the investigation will be completed.

Event Description

Intra-op breakage of the instrument with code (b)(4), lot 11h5257 occurred on the (b)(6) 2019: two little metal rods detached from the instrument.According to the info received, the issue was noted after the surgeon had finished using it, thus there were no consequences for the patient, nor prologation of the surgery time.Event happened in (b)(6).

• Brand Name: MANUAL SNAP WRENCH
• Type of Device: MANUAL SNAP WRENCH
• Manufacturer (Section D): LIMACORPORATE S.P.A.; via nazionale 52; villanova di san daniele, 33038 ; IT 33038
• MDR Report Key: 9415904
• MDR Text Key: 219764990
• Report Number: 3008021110-2019-00144
• Device Sequence Number: 1
• Product Code: HXC
• Combination Product (y/n): N
• PMA/PMN Number: CLASS I
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9095.10.110
• Device Catalogue Number: 9095.10.110
• Device Lot Number: 11H5257
• 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