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

Model Number	EL-DTS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age, date of birth, and weight not available for reporting.Device is an instrument and is not implanted/explanted.A review of the device history records has been requested.Subject device has been received and is currently in the evaluation process.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 fusion procedure on (b)(6) 2018, one (1) elite compression implant drilling template broke into fragments.Another drilling template was available at the time and was used to complete the procedure successfully with no delay.All fragments were reported to have been removed.The patient was reported in stable condition after the procedure.Concomitant devices reported: elite compression implant drill kit with 3.0 mm drill bit (part dk-300, lot number unknown, quantity 1).This report is for one (1) elite compression implant drilling template.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Corrected data: device manufacture date.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.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.Dhr review was completed.Part number: el-dts (dt-el30s) , bme lot number: bdt180006 , manufacturing date or release to warehouse date: 5 mar 2018 , place of manufacture: biomedical enterprises, san antonio, tx.Lot expiration date: 5 jan 2023.Dhr review: a review of the device history record revealed one nonconformance to be associated to lot bdt180006.The device history record shows this lot of elite drill guides was processed through the normal manufacturing and inspection operations with one nonconformance generated that could contribute to the complaint condition.The ncmr was generated due to 31 drill guides (dt-el30s) that broke when being assembled.Lot bdt180006 was released as conforming as all nonconforming parts were scrapped.Relevance to complaint condition cannot be determined until the product is returned for investigation.Nonetheless, this lot met all dimensional, visual, and packaging criteria at the time of release, and there are effective risk control points in place to make sure this type of nonconformance does not get to the field.The review of the raw material device history record revealed no complaint related anomalies.Raw material used in this lot met all dimensional and visual criteria at the time of release with no issues documented that would contribute to this complaint condition.Review of the device history record(s) showed there were potential issues during the manufacture of the product that would contribute to this complaint condition.Relevance to complaint condition cannot be determined until product is returned.Customer quality conducted an investigation of the returned device.The device was returned to and investigated by bme with the following results; visual inspection of the returned device showed that the drill guide was completely broken in half on one side of the base and cracked the same way on the other side.Dimensional inspection to the document specification was performed to verify the drill guide was within the required specifications.Not all ctq dimensions could be measured due to the condition of the device.Drill guide passed all dimensions that could be measured.Refer to attached inspection report.Packaging personnel were interviewed to check if the failure mode was the same being seen during assembly of these parts.Packaging personnel stated the breakage was not the same as the one seen in-house, the breaks that happen during assembly occur at the end tip of the tines, not the complete base of the template.Therefore, the nc was deemed not relevant based on the received condition.Thus, after physical inspection and interview of pertinent personnel, it was concluded that the breakage cannot be attributed to a manufacturing issue.Root cause for the breakage cannot be confirmed based on the information provided and the estate of the returned device.No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not required.However, appropriate steps have been taken to address the potential impact of the design to the complaint condition.No further corrective action is deemed necessary at this time.Conclusion: the complaint condition is confirmed and agrees with the complaint description as the drill guide is broken.An investigation was performed fulfilling the requirements of the ¿broken¿ investigation flow.A root cause could not be definitively determined.No manufacturing related issue was identified and/or confirmed.Appropriate steps have been taken to address the potential impact of the design to the 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: STAPLE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7462517
• Report Number: 2939274-2018-51925
• Device Sequence Number: 16417222
• Product Code: JDR
• UDI-Device Identifier: 00810633021965
• UDI-Public: (01)00810633021965
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/05/2018

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: 01/05/2023
• Device Model Number: EL-DTS
• Device Catalogue Number: EL-DTS
• Device Lot Number: BDT180006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 05/18/2018; 06/04/2018; 06/04/2018
• Initial Report FDA Received Date: 04/25/2018
• Supplement Report FDA Received Date: 05/18/2018; 06/04/2018; 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1