MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.5MM DRILL BIT/QC/GOLD/110MM; INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH

Catalog Number 310.25

Device Problem Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

Reported as (b)(6) 2018, exact date is not known.Additional product codes: gff, gfa, hsz device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a 2.5 mm drill bit was observed dull during an unknown patient procedure on (b)(6) 2018.The damaged device was set aside and another similar device was used to complete the procedure without incident.There was no surgical delay.No patient harm was reported.The patient outcome was reported successful.Concomitant devices reported: drill (part number unknown, lot number unknown, quantity 1).

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.Additional narrative: an investigation was performed for the subject device: part number: 310.25.Synthes lot number: u246646.Supplier lot number: n/a.Release to warehouse date: 21-jun-2016.Expiration date: n/a.Supplier: (b)(4).No nonconformances ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.A product development investigation was performed for the subject device: it was reported that a 2.5 mm drill bit was observed dull during an unknown patient procedure on (b)(6) 2018.The damaged device was set aside and another similar device was used to complete the procedure without incident.There was no surgical delay.No patient harm was reported.The patient outcome was reported successful.This complaint is confirmed.The returned drill bit is dull as reported.Additionally, the drill bit is bent.Whether this complaint can be replicated at customer quality (cq) is not applicable for this complaint condition.The returned drill bit was manufactured in june 2016 and is one month shy of being 2 years old.No ncrs were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The material and relevant material properties were determined to be conforming at the time of manufacture based on review of the dhr.Drawing 310_25 was reviewed during this investigation and determined to be suitable for the intended design, application and dimensional conformity when used as recommended.The 310.25 2.5mm drill bit/qc/gold/110mm is a reusable instrument routinely used to predrill bone for screws.The outside diameter of the returned bent and dull drill bit measured ø2.48mm at cq (calipers ca592) which is within specification of ø2.5mm +0/-0.025mm per drawing 310_25.The most likely cause for this drill bit becoming dull is cumulative wear from repeated use for nearly 2 years of service.The most likely cause for the device bending is the user applying additional force on the dull device in attempt to complete a drilling process even though the drill bit was already dull.No product design issues or manufacturing discrepancies were observed during this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Corrected data: udi.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.

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.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.

Event Description

It was reported that a 2.5 mm drill bit was observed dull during an unknown patient procedure on (b)(6) 2018.The damaged device was set aside and another similar device was used to complete the procedure without incident.There was no surgical delay.No patient harm was reported.The patient outcome was reported successful.The returned drill bit was observed to be bent at its distal portion.Concomitant devices reported: drill (unknown part and lot numbers, quantity:1).

• Brand Name: 2.5MM DRILL BIT/QC/GOLD/110MM
• Type of Device: INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7401071
• MDR Text Key: 104812798
• Report Number: 2939274-2018-51484
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 10886982186317
• UDI-Public: (01)10886982186317(10)U246646
• 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,Followup
• Report Date: 03/13/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 310.25
• Device Lot Number: U246646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Initial Date Manufacturer Received: 03/13/2018
• Initial Date FDA Received: 04/05/2018
• Supplement Dates Manufacturer Received: 04/09/2018; 05/10/2018
• Supplement Dates FDA Received: 04/30/2018; 05/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1