MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SPEEDTITAN COMPRESSION IMPLANT KIT 15X15MM; BONE STAPLE

Model Number	SE-1515TI
Medical Device Problem Codes	Break (1069); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Synthes rep.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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, during a field inventory, a two (2) speedtitan compression implant staples had broken through the plastic inserter device in the sterile packaging.The implant looks like they have been compromised and are not able to use for surgery.There was no patient involvement.This complaint involves two (2) devices.This report is 1 of 2 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.
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.Part: se-1515ti , bme lot: bmese160436 , manufacturing date or release to warehouse date: december 30, 2016 , place of manufacture: biomedical enterprises, san antonio, tx , lot expiration date: december 12, 2021.No nonconformance reports (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.Visual inspection: visual inspection was performed to determine the failure mode of this complaint.Inspection showed that the inserter broke at the island, confirming the complaint condition.Dimensional inspection: an accurate dimensional inspection of the returned device was not able to be performed because of the post manufacturing deformation.Document/ specification review: this is a known issue with se-1515ti.Relevant actions have been taken to address the issue.Review of the manufacturing record evaluation showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Investigation conclusion: the root cause of the issue was determined and previously addressed therefore, further investigation, including risk document review, will not be performed on this complaint.No manufacturing related issue was identified and/or confirmed.The potential impact of the design in the complaint condition has been addressed.No further corrective actions are required at this moment.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: SPEEDTITAN COMPRESSION IMPLANT KIT 15X15MM
• 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: 8843797
• Report Number: 2939274-2019-59462
• Device Sequence Number: 1412894
• Product Code: JDR
• UDI-Device Identifier: 00810633021514
• UDI-Public: (01)00810633021514
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 07/03/2019

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: 12/12/2021
• Device Model Number: SE-1515TI
• Device Catalogue Number: SE-1515TI
• Device Lot Number: BMESE160436
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 08/29/2019; 08/29/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 08/29/2019; 08/29/2019
• Patient Sequence Number: 1