MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EXTRACTOR SHAFT; HIP INSTRUMENTS : EXTRACTION INSTRUMENTS

Catalog Number	242204000
Medical Device Problem Codes	Device-Device Incompatibility (2919); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/14/2018
Type of Reportable Event	Serious Injury
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
Today during surgery the surgeon in (b)(6) needed to use this instrument.On attempt to put this together he felt the instrument was weak at the top and did not believe the threads to be fitting together properly.The two parts of the slap hammer that would not fit together are below.In addition due to this problem he was not able to remove a stem in situ, and the surgery was extended for 2 hours while we got another extraction kit from a local hospital.When using the same item from the new kit the stem came straight out.During surgery today when using the slap hammer, on removal of the stem the stem would not come off the end of the slap hammer.They seemed "welded" together.The surgeon was unhappy with this and deemed it to be a fault of the slap hammer.In addition he felt that this item was weak in removing the construct and believed the threads to cross if the slap hammer was used too vigorously, which is the nature of the tool being used.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.A worldwide lot specific complaint database search, or device history record (dhr) review, was not possible because the required lot code(s) was not provided.The investigation could not draw any conclusions regarding the reported event.Based on the inability to determine a root cause, the need for corrective action was not indicated.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXTRACTOR SHAFT
• Common Device Name: HIP INSTRUMENTS : EXTRACTION INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7670414
• Report Number: 1818910-2018-63980
• Device Sequence Number: 2580106
• Product Code: HWB
• UDI-Device Identifier: 10603295123033
• UDI-Public: 10603295123033
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 242204000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 10/05/2018
• 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: Required Intervention