MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA AMIS METAL TEETH CFIBER CHARNLEY BLADE LARGE; SURGICAL INSTRUMENT FOR HIP

Catalog Number	01.15.10.0146
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection performed by r&d project manager: during the analysis it is evaluated that some scratches are present on the blade body above the metal teeth: it seems that the user improperly hit the blade with such instrument during surgery.In addition some scratches are present around the holes for connection sleeve with charnley frame: it seems that the blade wasn't coupled correctly with the sleeve during the surgery.Batch review performed on 12 march 2019: lot 1754078: (b)(4) items manufactured and released on 22 january 2018.No anomalies found related to the problem.To date, other 3 similar events have been reported on this lot.
Event or Problem Description
The surgeon noticed that the carbon was peeling of the large carbon fibre charley blade and falling off into the patient.It seemed to peel off when a blunt hohmann was pushing against it.The surgeon got the fragments out of the patient successfully.
Additional Manufacturer Narrative
The complaints was notified to the supplier, who on the 5 april 2019 reported as follow about this batch: concerning your inquiry for medacta lot 1754078 (gsell ref: 515095-20), i reviewed the dhr for gsell ref: 515095-20 and can confirm the following: all production steps were performed as defined; all measurements are within the required limits; all inspections passed without any observations; the certificate of the raw material (lot: s-a17) is available and confirms that it was produced as required.Furthermore, we have retention samples of the raw material (lot: s-17): i reviewed all retention samples of this lot and can re-confirm, that these samples are acceptable according to our requirements (correct amount and orientation of layers).

• Brand Name: AMIS METAL TEETH CFIBER CHARNLEY BLADE LARGE
• Common Device Name: SURGICAL INSTRUMENT FOR HIP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8424794
• Report Number: 3005180920-2019-00157
• Device Sequence Number: 19145789
• Product Code: LXH
• UDI-Device Identifier: 07630040735384
• UDI-Public: 07630040735384
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/30/2019

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: 01.15.10.0146
• Device Lot Number: 1754078
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 04/30/2019
• 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: 62 YR
• Patient Weight: 82