MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 14MM CANNULATED DRILL BIT; BIT,DRILL

Model Number 03.033.004

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Reporter is jnj representative.Investigation summary: investigation flow: damage visual inspection: the 14mm cannulated drill bit flexible (p/n 03.033.004, lot # 5l56841) was received at us cq broken on the laser cut teeth segment on the shaft.The shaft was completely broken into 2 pieces.No other issues were identified with the returned components of the device.Device failure/defect identified? yes.Dimensional inspection: dimensional inspection of the received device was performed.Document/specification review: based on the date of manufacture relevant drawings are reflecting the current and manufactured revision were reviewed.Complaint confirmed? yes, the device received was broken.Hence confirming the allegation.Conclusion: the complaint was confirmed for the 14mm cannulated drill bit flexible (p/n 03.033.004, lot # 5l56841) as the shaft of the device was completely broken.The unintended external forces might have contributed to the reported complaint condition.There was no indication that a design or manufacturing issue has caused the breakage and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: part number: 03.033.004, lot number: 5l56841, manufacturing site: (b)(4), release to warehouse date: aug.20, 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's were identified.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, the reporter found six (6) damaged items in sterile processing department (spd).There was no patient involvement.This complaint involves six (6) devices.This report is for (1) 14mm cannulated drill bit.This is report 3 of 3 for (b)(4).

• Brand Name: 14MM CANNULATED DRILL BIT
• Type of Device: BIT,DRILL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10247751
• MDR Text Key: 198296968
• Report Number: 2939274-2020-03159
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 10886982271082
• UDI-Public: (01)10886982271082
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2020

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
• Device Operator: Health Professional
• Device Model Number: 03.033.004
• Device Catalogue Number: 03.033.004
• Device Lot Number: 5L56841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/08/2020
• Date Device Manufactured: 08/20/2019
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1