MAUDE Adverse Event Report: DEPUY SPINE INC XPDM PEDICLE PROBE, STRAIGHT

Model Number	279702010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Local Reaction (2035); Injury (2348); Blood Loss (2597); Foreign Body In Patient (2687); Not Applicable (3189)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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
Surgeon was using the straight, blunt pedicle probe to make a screw track and the probe broke off into the vertebral body of l5 on the left side.Patient consequence? yes.Patient consequence description: increased anesthesia time and blood loss.Part of the broken pedicle probe was retained in the patient.Surgeon had to extend the fusion 1 level, which was not planned.Is the information being submitted for this complaint all the details that are known/available regarding this event? yes.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination at the macroscopic level reveal that the fracture was located approximately 17mm from the probe¿s distal tip.The second half of the probe¿s tip was not returned for analysis.Device was then sent for fracture analysis.The fracture analysis report reveals torsional shear markings following a circular pattern.This suggests that the fractured tip underwent a quasi-static overload torsional shear failure.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the pedicle probe¿s distal tip fracturing cannot be positively determined.However, the fracture analysis suggests that the fractured tip underwent a quasi-static overload torsional shear failure.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: XPDM PEDICLE PROBE, STRAIGHT
• Common Device Name: PROBE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7553385
• Report Number: 1526439-2018-50500
• Device Sequence Number: 1187243
• Product Code: HXB
• UDI-Device Identifier: 10705034198415
• UDI-Public: (01)10705034198415
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 279702010
• Device Catalogue Number: 279702010
• Device Lot Number: NW196868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention