MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ELITE COMPRESSION IMPLANT DRILLING TEMPLATES; ELITE DRILL KIT - S SHAPED

Model Number	EL-DTS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on (b)(6) 2019, the elite compression implant drilling template broke into multiple pieces during surgery and the surgeon opened a secondary drill bit.The procedure was successfully completed with no surgical delay.Patient status is unknown.This complaint involves one (1) device.This report is 1 of 1 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.H10 additional narrative: b5; d4.H3, h4, h6: a device history record (dhr) review was conducted: part number: el-dts.Bme lot number: bdt180868.Manufacturing date or release to warehouse date: (b)(6) 2018.Place of manufacture: biomedical enterprises, san antonio, tx.Lot expiration date: 19 sep 2023.Dhr review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of elite s drill guides was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.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 one nonconformance to be associated to raw material lot ir-181148 (supplier lot # 306715, part #dt-el-18s-bm).The ncmr was generated due to components coming from the supplier with dirt marks.Lot 306715 was released as conforming as all nonconforming components were scrapped.The nonconformance is not relevant to the complaint because dirt marks would not contribute to the drill guide breaking during surgery, given the broken drill guide was a size 18s.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.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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 further reported that no fragments remained in the patient.

• Brand Name: ELITE COMPRESSION IMPLANT DRILLING TEMPLATES
• Common Device Name: ELITE DRILL KIT - S SHAPED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8274057
• Report Number: 2939274-2019-56032
• Device Sequence Number: 13941266
• Product Code: JDR
• UDI-Device Identifier: 00810633021965
• UDI-Public: (01)00810633021965
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 01/04/2019

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: 09/19/2023
• Device Model Number: EL-DTS
• Device Catalogue Number: EL-DTS
• Device Lot Number: BDT180868
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 03/04/2019
• Initial Report FDA Received Date: 01/24/2019
• Supplement Report FDA Received Date: 03/05/2019
• Patient Sequence Number: 1