MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEEDSHIFT COMPRESSION IMPLANT KIT 15X20X20MM OFFSET 8MM; BONE STAPLE

Model Number	SE-1520-08
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: initial reporter is a synthes sales consultant.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 speedshift compression implant inserter came off inside the sterile box.It is unknown when was the issue discovered.Procedure and patient involvement are unknown.This report is for a speed shift compression implant inserter.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.Additional information provided.Part: se-1520-08; bme lot: bse170848; manufacturing date or release to warehouse date: november 30, 2017; place of manufacture: biomedical enterprises, san antonio, tx; lot expiration date: november 7, 2022.No nonconformance reports (ncrs) were generated during production.Review of the device history record(s) (dhr) 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.Manufacturing investigation visual inspection was performed to determine a failure mode.Inspection showed that the inserter released the implant prematurely, therefore confirming the complaint description.No indications of damage to the product were found.Dimensional inspections were performed to verify the inserter and the implant were within acceptable manufacturing specifications.Both implant and insertion stick passed dimensional inspection.Based on investigation results and the information provided in the complaint, no definitive root cause could be determined for this complaint condition, however, it was determined that the most probable root cause is shipping/handling of the device.No manufacturing related issue was identified and/or confirmed.Relevant actions have been taken to address the issue.No further corrective action is required for this event.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.Lot number provided for reporting.Additional reporter provided is a synthes sales consultant.A review of the device history records has been requested.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Complainant part was returned for manufacturer review/investigation.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: SPEEDSHIFT COMPRESSION IMPLANT KIT 15X20X20MM OFFSET 8MM
• 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: 8197385
• Report Number: 2939274-2018-55581
• Device Sequence Number: 1579664
• Product Code: JDR
• UDI-Device Identifier: 00810633020432
• UDI-Public: (01)00810633020432
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K142292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2018

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 Expiration Date: 11/07/2022
• Device Model Number: SE-1520-08
• Device Catalogue Number: SE-1520-08
• Device Lot Number: BSE170848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Received by Manufacturer: 12/25/2018
• Supplement Date Received by Manufacturer: 01/11/2019; 02/27/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 01/30/2019; 02/27/2019
• Patient Sequence Number: 1