MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047; DRILL, BONE, POWERED

Catalog Number 03.503.476

Device Problem Break (1069)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

Manufacturer Narrative

Patient height reported as 5 feet 8 inches.Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A review of the device history records has been requested.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 Description

It was reported that the patient underwent an unknown procedure on an unknown date.During the procedure, the surgeon was drilling a hole to implant a screw and the drill bit broke off in the patient.An additional incision had to be made to retrieve the broken drill bit fragment.The entire drill bit was removed successfully.There was no harm to the patient beyond to the additional incision.There was a surgical delay of an unknown length due to the reported event, but the procedure was completed successfully.This is report 1 of 1 for (b)(4).

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 record (dhr) review: part # 03.503.476; synthes lot # u300058; supplier lot # u300058; release to warehouse date: 19jan2018; 21feb2018; supplier: (b)(4); the material was reviewed and the hardness value was confirmed to meet the specification with no (relevant) non-conformance noted.No nonconformance (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.Investigation summary: customer quality investigation: the following investigations were performed: broke: device condition: the drill bit shaft was received with a portion of the distal tip, broken off.Few broken fragments of the distal tip were not received.Furthermore,the portion of the broken tip that was returned was also observed to be bent.The complaint condition is consistent with the reported condition and complaint was confirmed.Dimensional analysis and document/specification review: based on the date of manufacture the following drawings, reflecting the current and manufactured revision, were reviewed.The diameter of the drill shaft at broken region was measured to be 1.5 mm (ca-814) which is within the specification of 1.5 mm +0.010/-0.014 per investigation summary.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.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.Also, material review performed during dhr records review showed no issues concerning the material and its properties.Conclusion: with the bent tip observed during visual inspection, the given complaint condition could possibly be the result of excessive force applied on the drive shaft resulting in stresses beyond the failure limit of the shaft.The root cause could not be definitively determined as the circumstances at the time of the break are unknown.However, no product design issues or manufacturing discrepancies were identified during this investigation.Therefore, 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: MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047
• Type of Device: DRILL, BONE, POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7695132
• MDR Text Key: 114205346
• Report Number: 2939274-2018-52928
• Device Sequence Number: 1
• Product Code: DZI
• UDI-Device Identifier: 10887587012971
• UDI-Public: (01)10887587012971
• Combination Product (y/n): N
• PMA/PMN Number: K043310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.503.476
• Device Lot Number: U300058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Date Manufacturer Received: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 61