MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM MILLING BIT-STERILE; BIT MILLING STERILE AND NON

Model Number 03.820.161S

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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.Product was not returned.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 Description

It was reported that on an unknown date, a milling bit broke while torquing during an unknown surgery.Chisels was used to complete the procedure.Surgical procedure was completed without surgical delay.Patient outcome is unknown.Concomitant device reported: unknown torque (part # unknown, lot# unknown, quantity 1).This report is for one (1) 2.0 mm milling bit.This is report 1 of 1 for complaint (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.Visual inspection: 2.0mm milling bit (p/n 03.820.161 lot unk) photos were received.Upon the provided photo investigation it is confirmed that the device is broken.No other issues were identified in the provided photos.Device failure/defect identified that breakage of the milling bit is confirmed.Dimensional inspection: dimensional inspection could not be conducted as the implant, and relevant parts, were not returned to us cq.Conclusion: the complaint condition is confirmed for 2.0mm milling bit (p/n 03.820.161 lot unk) as the provided photos showed breakage of the milling bit.While no definitive root cause could be determined, it is possible that condition was due to early excessive strain by patient or the milling bit was incorrectly locked (not properly torqued).During this investigation no product design or manufacturing issues were observed (based on provided photos) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: no combination could be found in jde or docusphere for part # 03.820.161 with lot # unknown, therefore a dhr review could not be performed at this time.If further information becomes available regarding the identifies for this part, then this dhr review will be revisited.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: 2.0MM MILLING BIT-STERILE
• Type of Device: BIT MILLING STERILE AND NON
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8906919
• MDR Text Key: 154773356
• Report Number: 2939274-2019-59898
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 10705034731858
• UDI-Public: (01)10705034731858
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.820.161S
• Device Catalogue Number: 03.820.161S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - TORQUE DEVICES; UNK - TORQUE DEVICES