MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEED COMPRESSION IMPLANT KIT 18X15X15MM; BONE STAPLE

Model Number SE-1815

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

Device used for treatment, not diagnosis.Patient sex, age & weight not available for reporting.This report is for an unknown common device name.Date returned to manufacturer.510k: this report is for an unknown 510k, not available in jde.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Device history records review was conducted.The report indicates that the: part number: se-1815, bme lot number: bmese160226, manufacturing date or release to warehouse date: 7 july 2016, place of manufacture: biomedical enterprises, san antonio, tx, lot expiration date: 8 june 2021.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.

Event Description

It was reported that during a surgery for tarsometatarsal fusion on (b)(6) 2018 a speed compression implant kit 18x15x15mm was not getting dislodged from the inserter.The surgery was completed using another available kit.There was no reported surgical delay and the patient was stable after the surgery.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

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.A product investigation was performed.Implant and inserter were received disassembled.Visual inspection showed that both implant and inserter were in good condition.Performed (b)(6) 2018.Dimensional inspections were performed to verify both implant and inserter were within specified manufacturing dimensions.Implant and inserter passed dimensional inspection.Refer to attached inspection reports.Performed (b)(6) 2018.Compression testing was performed.Implant showed to compress below the expected force range.However, compression force is not a requirement, therefore no compression value needs to be met.The test memo attached to this investigation is just for informational purposes.If implant was compressing above the recorded average value for that implant size, there may be the possibility that the implant is over-compressing causing it to grasp to the inserter, therefore not deploying.This root cause was discarded after testing.Test performed (b)(6) 2018.Thus, after physical inspection and testing of the returned devices, it was concluded that the root cause for deployment cannot be confirmed based on the information provided in this complaint.No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not required.Capa-007630 is open 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.It was previously reported on mwr-08032018-0000069509 that the event date was (b)(6) 2018.The correct event date is (b)(6) 2018.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 18X15X15MM
• Type of Device: BONE STAPLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7384305
• MDR Text Key: 104152978
• Report Number: 2939274-2018-51339
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 00810633020180
• UDI-Public: (01)00810633020180(10)BMESE160226
• Combination Product (y/n): N
• PMA/PMN Number: K142292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2021
• Device Model Number: SE-1815
• Device Catalogue Number: SE-1815
• Device Lot Number: BMESE160226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Date Manufacturer Received: 04/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR