MAUDE Adverse Event Report: DEPUY SPINE INC 6MM DUAL-LEAD TAP; ORTHOPAEDIC STEREOTAXIC INSTRU

Model Number	279702600N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Investigation summary.Photo investigation: the device was not returned.A photo-investigation was performed on the images provided.The attachment was an image of the broken 6mm dual-lead tap.Both broken pieces were visible in the image.The device was broken at the transition point to the smaller shaft; hence the complaint is confirmed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review could not be performed.Conclusion: the complaint condition was confirmed during photo investigation.Although no definitive root-cause can be determined based on the provided information, it is likely the device encountered unintended forces during use.No new, unique or different patient harms were identified as a result of this evaluation.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 preventive 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: the device lot number is unknown, therefore a mre review could not be performed.Also, a manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure (b)(4), no manufacturing record evaluation is required 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) 2021, during an unknown procedure the double lead 6.0 tap shaft snapped.There was no surgical delay.Fragments were generated and removed easily.There were no patient consequences.The procedure was successfully completed.This report is for one (1) 6mm dual-lead tap.This is report 1 of 1 for (b)(4).

• Brand Name: 6MM DUAL-LEAD TAP
• Common Device Name: ORTHOPAEDIC STEREOTAXIC INSTRU
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12174573
• Report Number: 1526439-2021-01412
• Device Sequence Number: 19240407
• Product Code: OLO
• UDI-Device Identifier: 10705034388366
• UDI-Public: 10705034388366
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K140927
• 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
• Report Date (Section B): 06/16/2021

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: 279702600N
• Device Catalogue Number: 279702600N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1