MAUDE Adverse Event Report: DEPUY IRELAND 9616671 GLOBAL UNITE BODY SZ 10 -5; TRIAL INSTRUMENT

Catalog Number	110030100
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2017
Type of Reportable Event	Malfunction
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 surgeon could not connect humeral stem and body component during the surgery because the shaft of the screw part to be connected with the stem of the body of the equipment was installed upside down when the surgeon opened the package.After the surgery, the surgeon found that it was possible to reassemble the screw shaft in the correct orientation by hand.It was brand new and the first use when the issue occurred.There was 5 min.Surgical delay and no harm to the patient.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for inspection.Examination of the provided photographs and review of the manufacturing records confirmed the reported event.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.
Additional Manufacturer Narrative
(b)(4).No device associated with this report was received for inspection.Examination of the provided photographs and review of the manufacturing records confirmed the reported event.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.Re-open upon receipt of the device.Evaluation of the returned device confirms the reported event.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: GLOBAL UNITE BODY SZ 10 -5
• Common Device Name: TRIAL INSTRUMENT
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7099959
• Report Number: 1818910-2017-51095
• Device Sequence Number: 16483284
• Product Code: HSD
• UDI-Device Identifier: 10603295004387
• UDI-Public: 10603295004387
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K101996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2017

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: 110030100
• Device Lot Number: 8556910
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2017
• Supplement Date Received by Manufacturer: 08/20/2018; 11/21/2018
• Initial Report FDA Received Date: 12/08/2017
• Supplement Report FDA Received Date: 09/04/2018; 12/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1