MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ANCHOR PLATE SIZE 52; SHOULDER HUMERAL STEM ACCESSORY

Catalog Number	114010052
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/31/2018
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
(b)(6).Clinical adverse event received for anterior wall fracture during implantation of humeral base plate.Event is not serious and is considered moderate.Event is definitely related to both device and procedure.Doi: (b)(6) 2018, doe: (b)(6) 2018, (left shoulder).
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: corrected: evaluation codes.Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.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.Device history lot: null.Device history batch: null.Device history review: null.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: ANCHOR PLATE SIZE 52
• Common Device Name: SHOULDER HUMERAL STEM ACCESSORY
• Manufacturer (Section D): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• MDR Report Key: 7645532
• Report Number: 1818910-2018-63423
• Device Sequence Number: 122046
• Product Code: KWS
• UDI-Device Identifier: 10603295381143
• UDI-Public: 10603295381143
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2018

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 114010052
• Device Lot Number: 8519242
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 12/11/2018; 12/11/2019
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 12/11/2018; 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 103