MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM SPINE SYSTEM DOUBLE-LEAD TAP, CANNULATED; TAP, BONE

Model Number	299704960
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date in 2021 during an unknown procedure, the surgeon was tapping tough sclerotic bone over the guidewire.Both verse cannulated taps snapped when preparing the pilot hole.Fragments were generated and removed using dolphin nosed pliers.The procedure was successfully completed using an alternative tap.There was a surgical delay of fifteen (15) minutes.There was no patient consequence.This report is for one (1) expedium spine system double-lead tap, cannulated 6mm 30-60mm plus or minus 1.67 percent.This is report 1 of 3 for (b)(4).
Additional Manufacturer Narrative
Date of event: event occurred on an unknown date in 2021.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Investigation summary: visual inspection: the 6mm double-lead tap, can (p/n: 299704960, lot number: pu108236) was received at us cq.Visual inspection of the complaint device showed the threaded tip of the device had broken off and broken fragment was returned.No other issues were observed with the complaint device.Device failure/defect identified? yes.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: this complaint was confirmed as the threaded distal tip had broken off.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 a review of the receiving inspection (ri) for 6mm double-lead tap, can was conducted identifying that lot number pu108236 was released in four batches.Batch1: lot was released on 26 may 2016 with no discrepancies.Batch2: lot was released on 26 may 2016 with no discrepancies.Batch3: lot was released on 18 may 2016 with no discrepancies.Batch4: lot was released on 18 may 2016 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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: EXPEDIUM SPINE SYSTEM DOUBLE-LEAD TAP, CANNULATED
• Common Device Name: TAP, BONE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 13010111
• Report Number: 1526439-2021-02554
• Device Sequence Number: 16585845
• Product Code: HWX
• UDI-Device Identifier: 10705034467023
• UDI-Public: 10705034467023
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 299704960
• Device Catalogue Number: 299704960
• Device Lot Number: PU108236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1.37MM GUIDEWIRE, BLUNT.; 5MM DOUBLE-LEAD TAP, CAN.; UNKNOWN SCREWS.
• Patient Sex: Unknown