MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMIS LARGE BLADE (H=75 MM); SURGICAL INSTRUMENT FOR HIP SURGERY

Catalog Number	01.15.10.0041
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 12 march 2019: lot 1652559: (b)(4) items manufactured and released on 14-nov-2016.No anomalies found related to the problem.To date, another similar event has been reported on this lot (complaint (b)(4) [mdr 2018-00775]).Preliminary investigation performed on 13 february 2019 by r&d product manager: the photos show the blade with the broken teeth.The charnley blades are instruments properly designed for amis approach and are widely used in the total hip arthroplasty providing a correct help during surgery.The root cause of the event can not be determined with certainty: probably the impingement with the head can be related to a choice of a too much big blade respect to the patient's size, as the terminal part of the blade (with the teeth) could have gone in impingent with the head; anyway, this remains only an hypothesis, as the size of the patient is unknown.
Event or Problem Description
During the hip reduction the ceramic ball head went in impingement with the medial blade.The surgeon noticed the broken teeth and removed them.After a c-arm check he swapped the ceramic head and completed the surgery successfully.
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: after visual inspection of the received devices i confirm what reported in the preliminary investigation.

• Brand Name: AMIS LARGE BLADE (H=75 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: 8421001
• Report Number: 3005180920-2019-00147
• Device Sequence Number: 2170363
• Product Code: LXH
• UDI-Device Identifier: 07630040734646
• UDI-Public: 07630040734646
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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: 01.15.10.0041
• Device Lot Number: 1652559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 05/15/2019
• 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: 61 YR
• Patient Weight: 65