MAUDE Adverse Event Report: SIGNATURE ORTHOPAEDICS PTY LIMITED LOGICAL STRAIGHT CUP INSERTER; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Model Number	112-152-384
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint records have been reviewed and no further complaints have been identified with the subject device batch.The dhr has been reviewed as part of the investigation.The part was found to be fully conforming with signature orthopaedics' specifications.The returned device was subject to engineering review.No errors in the product design were identified.Signature orthopaedics' ifu for instruments requires that instruments are inspected prior to use and that they are returned for inspection/repair by the manufacturer at least once every two years.These devices were in use since 10/2016.The root cause is misuse due to the use of the device with a damaged thread preventing proper assembly with the cup.
Event or Problem Description
The inserter instrument connects to the acetabular cup implant via threaded hole.It was reported that the inserter's tip broke off during cup insertion and that the broken piece remains in the threaded hole of the cup implant.

• Brand Name: LOGICAL STRAIGHT CUP INSERTER
• Common Device Name: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• Manufacturer (Section D): SIGNATURE ORTHOPAEDICS PTY LIMITED; 7 sirius road; lane cove west, nsw 2066 ; AS 2066
• MDR Report Key: 8419302
• Report Number: 3008262872-2019-00001
• Device Sequence Number: 13995832
• Product Code: LXH
• UDI-Device Identifier: 09348215039196
• UDI-Public: 09348215039196
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/14/2019

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 Model Number: 112-152-384
• Device Lot Number: 751A5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1