MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN TRIAL SHELL 54 STD PROFILE; HIP INSTRUMENTS : ACETABULAR TRIALS

Catalog Number	221701054
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	08/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Product code: 221750041 and 221701054, lot/batch/exp: shell only j0109.Was the product being used in a clinical trial? no.Did the event happen during a procedure? yes.Were you in the procedure at the time of the event? no.Event outcome/how was it managed? new set opened to insert cup.Was there any consequence to the patient due to the event? 2 min delay.Was the surgery prolonged due to the event? if yes, confirm how many minutes delay: 2 has the reporter facility indicated there may be legal action? no.Is the product available for return? no.Please give a detailed explanation of the event: inserter handle thread got stuck to the trial shell and couldn¿t be separated.
Additional Manufacturer Narrative
Product complaint # : (b)(4).The instrument associated with this report was not returned.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PIN TRIAL SHELL 54 STD PROFILE
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7859575
• Report Number: 1818910-2018-68796
• Device Sequence Number: 16640938
• Product Code: LXH
• UDI-Device Identifier: 10603295097655
• UDI-Public: 10603295097655
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 221701054
• Device Lot Number: J0109
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 11/06/2018
• Patient Sequence Number: 1