MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.2MM DRILL BIT/QC/145MM; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Catalog Number	310.31
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
510k#: device is a veterinary product.No patient information will be provided for reporting.Event date: unknown.Additional product codes: gff, gfa, hsz.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Without a lot number the device history records review could not be completed.Product was not returned.Device was used for treatment, not diagnosis.
Event or Problem Description
Veterinary complaint: it was reported that on an unknown date, nine (9) screws were incorrectly labeled and missing from the large fragment instrument set and the drill bit had a bad tip.This was discovered when the sets were received.There was no patient involvement.This complaint involves one (1) device.This veterinary complaint is 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.Reporter is synthes sales consultant.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.
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.Part: 310.31; synthes lot: u268926; supplier lot: u268926; release to warehouse date: june 30, 2017; supplier: orchid unique the material was reviewed, and the hardness value was confirmed to meet the specification with no relevant) non-conformance noted.No nonconformance reports (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.The following investigation flow was performed: damage: visual (appearance not as expected): visual inspection performed at customer quality (cq) observed that the cutting edge is chipped and dull preventing the device from functioning as intended.The received condition does agree with the complaint description for will not cut.Dimensional inspection: distal tip ø: 3.2 +0/- 0.03 mm.Measured ø: 3.19 mm; conforming.A device history review, was performed for the returned instrument¿s lot number and no material review reports (mrrs), ncrs, or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.A review of the current design drawing and the drawing revision at the time of manufacture was performed and no issues were identified.The complaint condition was confirmed.A definitive root cause for the given complaint condition could not be determined from the provided information.However, the device is a reusable device and constant use may have led to the dullness of the cutting edge.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.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: 3.2MM DRILL BIT/QC/145MM
• 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: 7945139
• Report Number: 2939274-2018-54247
• Device Sequence Number: 11326577
• Product Code: HWE
• UDI-Device Identifier: 10886982186478
• UDI-Public: (01)10886982186478
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/17/2018

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 Catalogue Number: 310.31
• Device Lot Number: U268926
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 10/25/2018; 11/05/2018
• Initial Report FDA Received Date: 10/08/2018
• Supplement Report FDA Received Date: 10/25/2018; 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1