MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEEDSHIFT COMPRESSION IMPLANT KIT 15X20X20MM OFFSET 10MM; BONE STAPLE

Model Number	SE-1520-10
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
Reporter is a synthes employee.Part: se-1520-10; bme lot: bse170414; manufacturing date or release to warehouse date: august 2, 2017; place of manufacture: (b)(4), lot expiration date: june 27, 2022.A review of the device history record revealed no relevant nonconformance.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.The review of the raw material device history record revealed no relevant nonconformance.This raw material lot met all dimensional and visual criteria at the time of release with no issues documented that would contribute to this complaint condition.Device evaluation: investigation flow: broken.Visual inspection: the speedshift compression implant kit 15x20mm offset 6mm was returned to biomedical enterprises, san antonio, tx for manufacturing evaluation.The results of the investigation are below: visual inspection was performed to determine a failure mode.Inspection showed that the inserter broke on the island feature, releasing the implant prematurely, therefore confirming the complaint description.Performed december 20, 2018.This is consistent with the reported complaint condition, thus confirming the complaint.The root cause for this failure mode has not been determined.Relevant actions have been taken to address the issue.No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not required.As escalation for this failure has already been performed, no further investigation steps will be performed as part of this complaint 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.
Event or Problem Description
It was reported that while preparing for an unknown procedure on an unknown date, the sales consultant discovered that two (2) 6mm speedshift compression implant kits and one (1) 10mm speedshift compression implant kit had come off the inserter inside the sterile package.It is unknown when was the issue discovered.There is no reported patient consequence.Procedure outcome is unknown.This report is for a speedshift compression implant kit 15x20x20mm offset 10mm.This is report 3 of 3 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 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 10MM
• 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: 8256598
• Report Number: 2939274-2019-55906
• Device Sequence Number: 2035136
• Product Code: JDR
• UDI-Device Identifier: 00810633020449
• UDI-Public: (01)00810633020449
• 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): 11/21/2018

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: 06/27/2022
• Device Model Number: SE-1520-10
• Device Catalogue Number: SE-1520-10
• Device Lot Number: BSE170414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 01/17/2019
• Supplement Report FDA Received Date: 01/17/2019
• Patient Sequence Number: 1