MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEED COMPRESSION IMPLANT KIT 15X12X12MM; BONE STAPLE

Model Number	SE-1512
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	01/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.The investigation could not be completed, no product was received; 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 on (b)(6) 2020, the patient underwent an unknown procedure.A surgeon was implanting a speed staple.The surgeon picked up the speed staple that was on the inserter and was trying to put the leg into the hole in the drill and the staple pop up prematurely.The surgeon commented that the speed staple was not on the inserter correctly.Another speed staple was opened to complete the surgery with about a minute of surgical delay.The patient's status is unknown.This is report 01 of 01 of (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.H3, h6: a product investigation was conducted.The following investigation was provided by the manufacturer, bme.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.Documentation / specification review: a documentation review was conducted which identified that a change to the packaging configuration for speed implant kit skus was implemented on 23-aug-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#: bse160451 was packaged on 29-dec-2016 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.Functional testing was not performed as the complaint device could not be handled due to biological contamination present on the device and decontamination services not being available at investigating site.Dimensional inspection was not performed as the complaint device could not be handled due to biological contamination present on the device and decontamination services not being available at investigating site.Conclusion: 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 though this could not be confirmed as the device was returned outside of original packaging.Appropriate actions have been take 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.No manufacturing defects or deficiencies were identified and/or confirmed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.H3, h4, h6: a device history record (dhr) review was conducted: part number: se-1512, bme lot number: bse160451, manufacturing date or release to warehouse date: 09jan2017, place of manufacture: biomedical enterprises, san antonio, tx, lot expiration date: 27dec2021.Dhr review: a review of the device history record lot#: bse160451 revealed this lot of se-1512 was processed through the normal manufacturing and inspection operations with one deviation: process deviation (pd) in qcbd was initiated to assemble this lot of se-1512 without inserting the instructions for use (ifu) in the implant box prior to external sterilization as ifus were out of stock at that time.The process deviation allowed for the ifus to be placed in the implant box and for boxes to be shrink wrapped after receipt from external sterilization when ifus would be back in stock.The process deviation is not relevant to the complaint condition because despite the change in operation order, the device was subjected to the same level of material handling as a device manufactured through a non-deviated process would be.This device 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.The review of the raw material implant device history record lot#: 1607120189 revealed this lot of t-se-1512 implants was processed through the normal manufacturing and inspection operations with two nonconformance events.The ncmrs were generated due to a lot shrinkage identified in process and due to one cosmetically defective implant identified during final visual inspection.Raw lot: 1607120189 was released as conforming as the lost & visually nonconforming implants did not affect conformity of remainder of lot.The nonconformances are not relevant to the complaint because neither lot shrinkage nor cosmetic defect rejection would have any effect on the conforming implants.This raw material implant lot met all dimensional and visual criteria at the time of release with no issues documented that would contribute to this complaint condition.Pd is not relevant to the complaint condition as the change in operation order did not increase overall material handling.Ncmrare not relevant to the complaint because neither event would impact remaining conforming product.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
Further it was reported that the reported event occurred during olecranon fracture procedure and patient's outcome is reported as positive.
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.H10 additional narrative: d10.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 15X12X12MM
• 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: 9716576
• Report Number: 2939274-2020-00869
• Device Sequence Number: 19552595
• Product Code: JDR
• UDI-Device Identifier: 00810633020166
• UDI-Public: (01)00810633020166
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/24/2020

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 Expiration Date: 12/27/2021
• Device Model Number: SE-1512
• Device Catalogue Number: SE-1512
• Device Lot Number: BSE160451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 03/24/2020; 07/09/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 03/24/2020; 07/17/2020
• Patient Sequence Number: 1
• Patient Age: 26 YR