MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA IMPACTOR FOR MOBILE LINER; SURGICAL INSTRUMENT FOR HIP

Catalog Number 01.26.10.0018

Device Problems Connection Problem (2900); Scratched Material (3020)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2015

Event Type  malfunction  

Event Description

When assembling the cup/head using the impactor, the corkscrew mechanism wouldn't engage into the green adaptor.In the process of trying to assemble the head and liner, the liner was scratched.A new liner had to be opened as the scrub tech was unable to successfully assemble the head and liner.This caused a slight delay in surgery and the surgeon was irritated at the impactors inability to function correctly.The agent did not have another impactor available to use and they had to use vice grips to assemble the copper screw manually before engaging the corkscrew to assemble the cup and liner.Mfr # 3005180920-2015-00164.

• Brand Name: IMPACTOR FOR MOBILE LINER
• Type of Device: SURGICAL INSTRUMENT FOR HIP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; castel san pietro ; SZ
• Manufacturer (Section G): MEDACTA USA INC.; 1556 w carroll ave; chicago IL 60607 000
• Manufacturer Contact: 1556 w carroll ave; chicago, IL 60607-0000
• MDR Report Key: 4959784
• MDR Text Key: 19988808
• Report Number: 3006639916-2015-00164
• Device Sequence Number: 1
• Product Code: LXT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/30/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: 01.26.10.0018
• Device Lot Number: 1312934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/30/2015
• Distributor Facility Aware Date: 07/09/2015
• Device Age: 22 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/30/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (B)(4); DM 01.26.2856MHC HC LINER 56/28: LOT #15029,
• Patient Outcome(s): Other
• Patient Age: 42 YR