MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMIS LARGE BLADE (H=101 MM); SURGICAL INSTRUMENT FOR HIP SURGERY

Catalog Number	01.15.10.0084
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 01 april 2019: lot 1851789: (b)(4) items manufactured and released on 24-aug-2018.No anomalies found related to the problem.To date, no similar event has been reported on this lot.Visual inspection performed by r&d (b)(4): during the analysis it was noticed that the geometry of the right fork where the tooth is missing had a deformation.It is possible that the root cause is related to a bad usage of the instrument, different from its intended use.
Event or Problem Description
After taking out the blade from the scar it was noticed that one tooth was broken.The broken part was found and removed from the patient's body.The surgery was completed successfully.

• Brand Name: AMIS LARGE BLADE (H=101 MM)
• Common Device Name: SURGICAL INSTRUMENT FOR HIP SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8482789
• Report Number: 3005180920-2019-00225
• Device Sequence Number: 16511744
• Product Code: LXH
• UDI-Device Identifier: 07630040735087
• UDI-Public: 07630040735087
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 01.15.10.0084
• Device Lot Number: 1851789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Weight: 80