MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIX 1.4MM DRILL BIT/J-LATCH CALIBRATED F/BASIC TROCAR SYS; DRILL, BONE, POWERED

Catalog Number	03.511.343
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product codes: erl, hbe.Device is an instrument and is not implanted/explanted.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 a matrix 1.4 mm drill bit/j-latch calibrated f/basic trocar system broke into three pieces during a mandibular osteotomy on (b)(6) 2018.There was a twenty-minute surgical delay related to retrieving the broken fragments from the patient's bone.All fragments were retrieved.No x-rays are available.The procedure was completed successfully with no patient harm.This report is for one (1) matrix 1.4 mm drill bit/j-latch calibrated f/basic trocar sys.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part # 03.511.343, synthes lot # u160461, supplier lot # u160461: release to warehouse date: 01 oct 2012, supplier: (b)(4).Unique: no non-conformance reports (ncrs) 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 sub-components, which would contribute to this complaint condition.A product investigation was performed.Device condition: the drill bit (part 03.511.343, lot u160461, mfg 01 oct 2012) was received at us cq broken.The drill bit has broken into three pieces, both breaks are within the fluted section of the bit.The complaint condition was visually confirmed and consistent with the reported condition.Replication of the complaint condition is not applicable as the devices were returned broken.The material, and material properties of the returned part were determined to be conforming at the time of manufacture based on review of the dhr(s).Drawing review: relevant drawing(s) was reviewed.Dimensional analysis was not performed as relevant features are significantly deformed.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition is confirmed as the device (part 03.511.343, lot u160461) was received broken.A device inspection, device history record review and drawing review were performed as part of this investigation.There is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined it is possible that the device encountered unintended forces (such as being over torqued or damaged during sterile processing).No new malfunctions were observed during the course of this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: MATRIX 1.4MM DRILL BIT/J-LATCH CALIBRATED F/BASIC TROCAR SYS
• Common Device Name: DRILL, BONE, POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7286564
• Report Number: 2939274-2018-50700
• Device Sequence Number: 13768345
• Product Code: DZI
• UDI-Device Identifier: 10887587014456
• UDI-Public: (01)10887587014456(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K043310
• 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
• Report Date (Section B): 01/25/2018

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 Catalogue Number: 03.511.343
• Device Lot Number: U160461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Initial Date Received by Manufacturer: 01/25/2018
• Supplement Date Received by Manufacturer: 02/23/2018; 03/28/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 03/21/2018; 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 60