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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 50

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MEDACTA INTERNATIONAL SA MPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 50 Back to Search Results
Catalog Number 01.32.6550
Device Problem Bent (1059)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/02/2017
Event Type  Malfunction  
Manufacturer Narrative

Additional information received on 09 june 2017 and includes: if the surgeon continued to tighten the screw, he would have broken it. The surgeon used the universal handle. Batch review performed on 26 june 2017. Lot 132489: (b)(4) items manufactured and released on 11 december 2013. Expiration date: 2018-06-30. No anomalies found related to the problem. To date, (b)(4) items of the same lot have been already sold without any similar reported event. Not yet received.

 
Event Description

When the surgeon was implanting the screw, the screw bent. The surgeon used a smaller screw to complete the surgery. There was a short delay of less than 2 minutes. The surgery was completed successfully. X-rays are not available; implant is available.

 
Manufacturer Narrative

On 04 july 2017 the r&d project manager performed a visual inspection of the retrieved item and commented as follows: the piece was analyzed. The screw is bent in the part closed to the screw head. It is not clear how it was happened and we can not determinate with certainty the root cause of the event, but we can assume that it is due to an erroneous use during surgery: in order to correct the direction of insertion, the surgeon would have applied a force in flexion to provide the bending of the acetabular screw.

 
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Brand NameMPACT CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 50
Type of DeviceCANCELLOUS BONE SCREW
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ 6874
Manufacturer (Section G)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, 6874
SZ 6874
Manufacturer Contact
stefano baj
strada regina
castel san pietro, 6874
SZ   6874
MDR Report Key6680312
MDR Text Key79037856
Report Number3005180920-2017-00350
Device Sequence Number1
Product Code LPH
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK132879
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/27/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/30/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2018
Device Catalogue Number01.32.6550
Device LOT Number132489
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/30/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/02/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/11/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 06/30/2017 Patient Sequence Number: 1
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