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 Consequences Or Impact To Patient (2199)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information is unknown device is an instrument and is not implanted/explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter phone number and email is not available for reporting reporter is a synthes sales consultant.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during a foot surgery procedure on (b)(6) 2018, the 25mm drill guide from elite compression implant drilling templates (el-dts) broke during drilling.It was noted that the broken pieces were recovered and new drill kit was used.There was no patient consequence reported.It was unknown if there was a surgical delay.Procedure outcome was unknown.This is report 1 of 1 for (b)(4).
Event or Problem Description
It was further reported that procedure was completed successfully with no delay.
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 history records review was completed for part# el-dts, lot# bdt180080.Manufacturing location: biomedical enterprises, san antonio, tx, manufacturing date: mar 05, 2018, expiry date: jan 29, 2023.The device history record shows this lot of elite drill templates was processed through the normal manufacturing and inspection operations with one nonconformance generated that could contribute to the complaint condition.Relevance to complaint condition cannot be determined until the product is returned for investigation.Review of the dhr showed there were potential issues during the manufacture of the product that would contribute to this complaint condition.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: 7679306
• Report Number: 2939274-2018-52821
• Device Sequence Number: 1370359
• Product Code: JDR
• UDI-Device Identifier: 00810633021965
• UDI-Public: (01)00810633021965
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2018

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: 01/29/2023
• Device Model Number: EL-DTS
• Device Catalogue Number: EL-DTS
• Device Lot Number: BDT180080
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 08/22/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR