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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(4).Additional product code: (b)(4).Reporter is a j&j representative.The investigation could not be completed, no product was received; 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 an unknown date, during a routine incoming inspection of a loaner set at fsl ups lyndhurst, nj site, it was observed that the 13.0mm cannulated drill bit 300mm was broken.There was no known patient or hospital involvement.This complaint involves one (1) device.This report is for (1) 13.0mm cannulated drill bit 300mm this is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This complaint is not confirmed as the complaint device is not broken.However, there is an unknown device that cannot be removed from the complaint device.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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 : product code #: 351.27.Synthes lot #: u351784.Supplier lot #: u351784.Released to warehouse: 05mar2020.Supplier: orchid unique.No 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.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: visual inspection: the 13.0mm cannulated drill bit 300mm (p/n: 351.27, lot number: u351784) was received at us cq.Visual inspection of the complaint device showed no damage or defects with the complaint device.However, an unknown device was stuck inside the drill bit and was unable to be removed.This unknown device is possibly a guide wire.Functional test: a functional assessment was performed on the complaint device and the unknown device.The devices were unable to be separated.The condition was able to be replicated.Dimensional inspection: a dimensional inspection was not performed due to the unknown device blocking the relevant dimensions.Document/specification review: no design issues or discrepancies were identified.Investigation conclusion: this complaint is not confirmed as the complaint device is not broken.However, there is an unknown device that cannot be removed from the complaint device.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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 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: 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
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12919226
• Report Number: 2939274-2021-06921
• Device Sequence Number: 5718685
• Product Code: HWE
• UDI-Device Identifier: 10886982193797
• UDI-Public: (01)10886982193797
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2021

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: U351784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 12/22/2021; 01/18/2022
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 12/28/2021; 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown