MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ELITE COMPRESSION IMPLANT 20X20X20X20X20 4 LEGS; BONE STAPLE

Model Number	EL-252013H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown.Date of implantation is unknown.Device has not been explanted.Device is not expected to be returned for manufacturer review/investigation.Initial reporter address and telephone not available for reporting.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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, patient had a follow-up and surgeon noticed a broken elite compression implant in talonavicular (tn) joint based on an x-ray review.It is unknown when the device was originally implanted.Patient had no complaints of pain or any symptoms.There was no revision procedure performed.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.Device evaluation: investigation type: x-ray review.The device was not received for evaluation.The provided medical images were reviewed at bme with the following results.¿investigation was performed based on x-rays provided in the attached file ((b)(4) xray image (b)(6) 2018).The x-rays show one broken elite h staple (el-202013h).The staple is implanted on the tn joint and has one broken leg at the shoulder.A dhr review on this implant could not be performed as the lot number was not provided.A relevant drawing for the device was reviewed during the investigation (the drawing at the time of manufacture is current), elite-h series post tumbling inspection.During the investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Device was not returned to customer quality (cq) for device evaluation, therefore, material assessment or dimensional inspection could not be performed.¿ conclusion: in conclusion, the complaint condition is confirmed as a broken elite h staple was observed in the provided medical images.During the investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.
Event or Problem Description
This report is for one (1) elite compression implant 20x20x20x20x20 4 legs.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Investigation summary: background: it was reported that on an unknown date, patient had a follow-up and surgeon noticed a broken elite compression implant in talonavicular (tn) joint based on an x-ray review.It is unknown when the device was originally implanted.Patient had no complaints of pain or any symptoms.There was no revision procedure performed.Device evaluation: investigation type: x-ray review.The device was not received for evaluation.The provided medical images were reviewed at bme with the following results.Investigation was performed based on x-rays provided.The x-rays show one broken elite h staple (el-202013h).The staple is implanted on the tn joint and has one broken leg at the shoulder.A dhr review on this implant could not be performed as the lot number was not provided.A relevant drawing for the device was reviewed during the investigation.During the investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Device was not returned to customer quality (cq) for device evaluation, therefore, material assessment or dimensional inspection could not be performed.¿ conclusion: in conclusion, the complaint condition is confirmed as a broken elite h staple was observed in the provided medical images.During the investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 COMPRESSION IMPLANT 20X20X20X20X20 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: 7905193
• Report Number: 2939274-2018-53938
• Device Sequence Number: 1807171
• Product Code: JDR
• UDI-Device Identifier: 00810633021743
• UDI-Public: (01)00810633021743
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Followup
• Report Date (Section B): 08/27/2018

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 Model Number: EL-252013H
• Device Catalogue Number: EL-202013H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 10/17/2018; 10/25/2018; 10/26/2018
• Initial Report FDA Received Date: 09/25/2018
• Supplement Report FDA Received Date: 10/23/2018; 10/25/2018; 10/29/2018
• Patient Sequence Number: 1