MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REAMER CPL; INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH

Model Number	03.168.004
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is jnj representative.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 on (b)(6) 2020, a complete reamer for the femoral system placed, seems very dull and need to replace.There was no patient involvement.This complaint involves one (1) device.This report is for (1)complete opening drill bit/ reamer assembly.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H6: investigation summary background: 12/7/2020: updated event description.It was reported that on (b)(6) 2020, a complete reamer for the femoral system placed, seems very dull and need to replace.There was no patient involvement.This complaint involves one (1) device.H3, h4, h6: device history lot: part: 03.168.004.Lot: f-24841.Manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: 17.Sep.2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Investigation flow: damage.Visual inspection: the complete opening drill bit/ reamer assembly was received at us cq with all the subcomponents.Upon visual inspection, it was observed that the cutting features (flutes) of the drill bit and reamer sub-components were slightly blunt and worn.Due to the worn condition of the cutting edges, device functionality was compromised.The noted issues were consistent as the end of life indicators for the device.Conclusion: the complaint was confirmed for the received device.After a visual inspection per guidance provided, it is determined that the reusable instrument is worn from repeated use and servicing; 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 preventive action is not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Updated manufacture date to 9/17/2018, (h4) and removed the expiration date, (d4).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: REAMER CPL
• 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: 11083848
• Report Number: 2939274-2020-05739
• Device Sequence Number: 3000380
• Product Code: HWE
• UDI-Device Identifier: 10886982274717
• UDI-Public: (01)10886982274717
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

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
• Operator of Device: Health Professional
• Device Model Number: 03.168.004
• Device Catalogue Number: 03.168.004
• Device Lot Number: F-24841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 01/20/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REAMER CPL