MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ELITE COMPRESSION IMPLANT DRILLING TEMPLATES; BONE STAPLE

Model Number	EL-DTS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(6) 2018, an elite compression implant broke during an unknown procedure.The surgeon got a large subtalar boot and torqued which broke the plastic/metal sleeve.There were plastic fragments generated from broken device.It was noted that the use of bouncing screws off and around each other was done since it can't be done with staples.There was no surgical delay.Procedure was successfully completed.Patient outcome was unknown.Concomitant devices reported: unknown screw (part # unknown, lot # unknown, quantity # unknown), unknown plate (part # unknown, lot # unknown, quantity # unknown).This report is for one (1) elite compression implant drilling templates.This is report 1 of 1 for complaint (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.No product was returned; the investigation was performed based upon a review of the received medical images.Upon review of the medical images, it can be confirmed that the drilling template is broken.The cause for the damage is not able to be determined.Manufacturing investigation investigation was performed based on the provided picture.The picture shows a broken 30mm elite drill guide.The drill guide broke on the two left inserts, which confirms the complaint description.A device history record (dhr) review on this instrument could not be performed as the lot number was not provided.A relevant drawing for the device was reviewed during the investigation (the drawing at the time of manufacture is current).This is a known issue with the elite drill guides, due to the press-in operation within the assembly process of the drill guides.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.No further corrective action is deemed necessary at this time.Device was not returned to cq for device evaluation, therefore, material assessment or dimensional inspection could not be performed.Risk documentation relevant actions have been taken to address the issue.No further actions are required at this moment.Conclusion: it has been determined that no further corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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
Surgeon stated that they are used to having screws bounce off and around each other; it can¿t be done with staples.
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.A review of the device history record device history lot null, dhr review, part number: el-dts, bme lot number: bdt180700, manufacturing date or release to warehouse date: 3 aug 2018, place of manufacture: biomedical enterprises, san antonio, tx, lot expiration date: 17 july 2023.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.Device history batch null,null, device history review null,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.Investigation summary background: it was reported that an elite compression implant broke during an unknown procedure no product was returned; the investigation was performed based upon a review of the received medical images attached to the main complaint "(b)(4) intake email with device image received from j&j employee 20dec2018").Upon review of the medical images, it can be confirmed that the drilling template is broken.The cause for the damage is not able to be determined.Manufacturing investigation investigation was performed based on picture provided in the attached file ((b)(4) additional information from sales consultant 10jan2019).The picture shows a broken 30mm elite drill guide.The drill guide broke on the two left inserts, which confirms the complaint description.No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not required.However, the potential impact of the design to the complaint condition is addressed under capa-007823.No further corrective action is deemed necessary at this time.Device was not returned to cq for device evaluation, therefore, material assessment or dimensional inspection could not be performed.Manufacturing investigation description visual inspection of the returned devices showed that the 30mm drill guide was completely broken on one side of the base (refer to returned device pictures in complaint), therefore confirming the complaint condition.Performed 20 june 2019.No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not required.However, the potential impact of the design to the complaint condition is addressed under capa-007823.No further corrective action is deemed necessary at this time.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: ELITE COMPRESSION IMPLANT DRILLING TEMPLATES
• 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: 8250674
• Report Number: 2939274-2019-55873
• Device Sequence Number: 13842329
• Product Code: JDR
• UDI-Device Identifier: 00810633021965
• UDI-Public: (01)00810633021965
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2023
• Device Model Number: EL-DTS
• Device Catalogue Number: EL-DTS
• Device Lot Number: BDT180700
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 02/15/2019; 07/01/2019; 07/12/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 02/15/2019; 07/11/2019; 07/22/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention