MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EPIPHYSEAL DISK MODULAR SZ1; SHOULDER INSTRUMENT/TRIAL

Catalog Number	230777003
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	09/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
It was reported that the epi 1 top hat would not fill over the sleeve and got stuck during surgery.
Additional Manufacturer Narrative
Investigation summary examination of the returned device confirmed the reported event.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may 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.
Event or Problem Description
Complaint description: it was reported that the epi 1 top hat would not fill over the sleeves and got stuck during surgery.Investigation method: november 14, 2017: complaint sample devices shipped by (b)(6).Awb# to be determined.Caughell investigation summary: it was reported that the epi 1 top hat would not fill over the sleeves and got stuck during surgery.

• Brand Name: EPIPHYSEAL DISK MODULAR SZ1
• Common Device Name: SHOULDER INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 6968308
• Report Number: 1818910-2017-27247
• Device Sequence Number: 13780667
• Product Code: HSD
• UDI-Device Identifier: 10603295116226
• UDI-Public: 10603295116226
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K062250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2017

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 Catalogue Number: 230777003
• Device Lot Number: 5259392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR