MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 13.0MM CANNULATED DRILL BIT 300MM; INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH

Model Number	351.27
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product codes: gfa, gff, hsz.A review of the device history records has been requested.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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 during an unknown surgical procedure on (b)(6) 2018, it was noted that the 13.0mm cannulated drill bit was dull and would not drill into the bone.Another drill bit was used to complete the procedure.This report is for one (1) 13.0mm cannulated drill bit.This is report 1 of 1 for (b)(4).
Additional 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 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 during an unknown surgical procedure on (b)(6) 2018, it was noted that the 13.0mm cannulated drill bit was dull and would not drill into the bone.Another drill bit was used to complete the procedure.Patient outcome was not reported.
Additional 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.A review of the device history part # 351.27, synthes lot # u281560, supplier lot # u281560, release to warehouse date: 14 dec 2017, supplier: (b)(4), no ncr's were generated during production.Device history review: 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.Device evaluation investigation flow: damage: visual (appearance not as expected) visual inspection the 13.0 mm cannulated drill bit 300 mm (part 351.27, lot u281560) was received was returned to us customer quality.Upon visual inspection, the cutting blades were noted to be blunt at the corners due to repeated use.Overall, the device appeared dull.Several scratches and nicks were present on non-cutting surfaces.There remaining of the device showed surface wear consistent with use and handling.This received condition agrees with the complaint condition, thus confirming the complaint.Conclusion the visual inspection revealed that the device shows end of life indicators (blunting of cutting edges due to multiple use, damage due to impact (non-impaction surface), rounding of sharp edges) which have resulted in the complaint condition.Per guidance provided in windchill, it is determined that the reusable instrument is worn from repeated use; therefore, further investigation for the reported complaint device is not required.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition; therefore, further corrective and/or preventative action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device was used for treatment, not diagnosis.

• Brand Name: 13.0MM CANNULATED DRILL BIT 300MM
• Common Device Name: 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: 8065147
• Report Number: 2939274-2018-54946
• Device Sequence Number: 11367242
• Product Code: HWE
• UDI-Device Identifier: 10886982193797
• UDI-Public: (01)10886982193797
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2018

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 Model Number: 351.27
• Device Catalogue Number: 351.27
• Device Lot Number: U281560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Initial Date Received by Manufacturer: 10/26/2018
• Supplement Date Received by Manufacturer: 12/18/2018; 12/20/2018
• Initial Report FDA Received Date: 11/13/2018
• Supplement Report FDA Received Date: 12/19/2018; 12/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1