MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ELITE COMPRESSION IMPLANT 25X20X20X20X20 4 LEGS; BONE STAPLE

Model Number	EL-252007Y4
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter is synthes sales representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.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 on an unknown date, the two (2) elite compression implants were received with product packaging issue.The box was incorrect.The label on the implant matched.There was no patient involvement.This report is for one (1) elite compression implant 25x20x20x20x20 4 legs.This is report 1 of 1 for (b)(4).
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.The initial complaint was reviewed and found not reportable.The pec coding was reviewed by regulatory manager, clinicians and cq investigation team lead/ engineer and with the information available, this event will be captured as a labeling issue (labeling, incorrect) and is not reportable.Pec code updated, reportability changed from reportable to not reportable.20-june-2019.

• Brand Name: ELITE COMPRESSION IMPLANT 25X20X20X20X20 4 LEGS
• Common Device Name: BONE STAPLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8636611
• Report Number: 2939274-2019-58220
• Device Sequence Number: 16711421
• Product Code: JDR
• UDI-Device Identifier: 00810633021798
• UDI-Public: (01)00810633021798
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K150125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

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 Expiration Date: 08/03/2023
• Device Model Number: EL-252007Y4
• Device Catalogue Number: EL-252007Y4
• Device Lot Number: BEL180757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 06/21/2019
• Patient Sequence Number: 1