MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEED COMPRESSION IMPLANT KIT 20X15X15MM; BONE STAPLE

Model Number	SE-2015
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
(b)(6).The device has been 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, while restocking the sterile implant tote, it was noticed that the staple was deployed from the handle in the package.This renders the device unusable.There was no patient involvement.This report involves one (1) speed compression implant kit 20x15x15mm.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 cause in or contributed to the pnfentatioe is unknown, not available or.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: a product investigation was conducted.Visual inspection: visual inspection of the returned device identified that there was no visible damage to inserter assembly or implant.Inspection identified that the implant was fully deployed from its inserter and that the inserter release button was actuated in the lowered position.Functional test: a functional test was not performed as the complaint condition can be visually confirmed and the item was still in its original sealed package.Dimensional inspection: a dimensional analysis was performed because there is a known issue with the design of the device and a corrective and preventative action (capa) has been issued to address it.Document/specification review: speed implant, speed implant kit assembly based on the review of the above drawings a change to the packaging configuration for speed implant kit skus was implemented on (b)(6) 2018.The change requires that speed implant kits are now packaged with the inserter release button facing down, instead of facing up, to reduce the risk of actuation of the release button through the packaging tray during transit/handling prior to opening.Lot# bse170537 was packaged on (b)(6) 2017 prior to implementation of the revised packaging method suggesting a potential cause of the complaint condition is the use of the historical speed implant kit packaging design though this could not be confirmed as the device was returned outside of original packaging.Conclusion: the complaint condition is confirmed as the staple has been deployed while still in its original packaging.Based on the investigation conducted, it has been determined that the most probable root cause for this type of complaint is the historical packaging design, with transit/handling being a contributing factor.Corrective and preventative action (capa) has been taken to address the design remediation of all bme product lines, which encompasses the design upgrade of speed from the current button inserters to slider inserters.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a device history record (dhr) review was conducted: part number: se-2015.Synthes lot number: bse170537.Supplier lot number: n/a.Release to warehouse date: (b)(6) 2017.Expiration date: n/a.Manufactured by (b)(4).No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which 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.

• Brand Name: SPEED COMPRESSION IMPLANT KIT 20X15X15MM
• 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: 9904336
• Report Number: 2939274-2020-01618
• Device Sequence Number: 11442666
• Product Code: JDR
• UDI-Device Identifier: 00810633020210
• UDI-Public: (01)00810633020210
• Combination Product (Y/N): N
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2020

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: SE-2015
• Device Catalogue Number: SE-2015
• Device Lot Number: BSE170537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Initial Date Received by Manufacturer: 03/04/2020
• Supplement Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1