MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ELITE 20 X 20 X 20 MM (2 LEGS) STRAIGHT IMPLANT; BONE STAPLE

Model Number	EL-2020S2
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Expiration date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.A review of the device history records has been requested.The investigation could not be completed; 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 (b)(6) 2019, during a foot surgery the elite compression implant kit did not deploy from the inserter.They used another one to complete the procedure.It was unknown if there a surgical delay.Procedure was successfully completed.There was no patient consequence.Concomitant device reported: unknown insertion instrument (part #: unknown, lot #: unknown, quantity #: 1).This complaint involves one (1) device.This report is 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 picture showed an el-2020s2 staple.The staple is shown deployed inside the tray without the inserter, therefore the complaint condition (implant did not deploy from the inserter) cannot be confirmed.A relevant drawing for the device was reviewed during the investigation.Implant appears to be in its open state, which would not contribute to the complaint condition.Implants are inspected for this during production, therefore this is not a manufacturing issue.No manufacturing related issue was identified and/or confirmed.No issues regarding the devices design were identified during investigation.No corrective action is deemed necessary at this time.Device was not returned to customer quality for device evaluation, therefore, material assessment or dimensional inspection could not be performed.Device history lot: part number: el-2020s2, bme lot number: bel170641, manufacturing date or release to warehouse date: 26 oct 2017, place of manufacture: biomedical enterprises, san antonio, tx, lot expiration date: 18 sep 2022.Dhr review: no ncmrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.This lot met all dimensional, visual, and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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.
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.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.

• Brand Name: ELITE 20 X 20 X 20 MM (2 LEGS) STRAIGHT IMPLANT
• 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: 8579079
• Report Number: 2939274-2019-57827
• Device Sequence Number: 16689393
• Product Code: JDR
• UDI-Device Identifier: 00810633021699
• UDI-Public: (01)00810633021699
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2019

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: 09/18/2022
• Device Model Number: EL-2020S2
• Device Catalogue Number: EL-2020S2
• Device Lot Number: BEL170641
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 05/09/2019; 05/09/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 05/10/2019; 06/03/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN INSERTION INSTRUMENT