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

Catalog Number	110030100
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2017
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
Account name: (b)(6).The reported device was going to use for artificial shoulder head insertion surgery on (b)(6) 2017.It was reported that the surgeon could not connect humeral stem (10mm standard) and body component (the reported device) 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.(please see photo 1).The surgery was completed by using the device which the surgeon reassembled the screw shaft in correct orientation by using female hex driver (please see photo 2 and 3).The photos show the reproduced situation of the defect by using sales sample.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.Device history lot: dhr review product code: (b)(4), work order (b)(4) was manufactured on (b)(4) 2017.(b)(4) parts were manufactured per specification and all raw materials met specification.(b)(4) parts were scrapped at for part marking, this scrap has no correlation with the failure mode.There were no ncs or deviations associated with this lot.Due to no similar failures found in the dhr review, the root cause of the complaint cannot be determined.Should further information come available that impacts the findings in this investigation it will be reopened.Root cause category: undetermined: insufficient information.Root cause determination: as the complaint has not been verified, it is not possible to establish a root cause.Corrective action/ follow-up: as the complaint has been deemed non-verifiable, it is not possible to establish corrective action.Complaint confirmed?: non-verifiable corrective action type: c/a not taken 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: SHOULDER INSTRUMENT/TRIAL
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• MDR Report Key: 7096966
• Report Number: 1818910-2017-50988
• Device Sequence Number: 917154
• Product Code: HSD
• UDI-Device Identifier: 10603295004387
• UDI-Public: 10603295004387
• Combination Product (Y/N): N
• PMA/510(K) Number: K101996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2017

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: 11/09/2017
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 12/07/2017
• Supplement Report FDA Received Date: 09/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1