MAUDE Adverse Event Report: DEPUY SPINE INC XPDM THORACIC PEDICLE PRB, CRV; PROBE

Model Number	279702040
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Excessive Tear Production (2235); Spinal Cord Injury (2432)
Date of Event	12/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).(b)(6).(b)(4) 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
It was reported that, during surgery, dr.(b)(6) was using the expedium pedicle probe to prepare the pedicle for screw insertion into the left side of s1 (sacral 1).He had just commented how hard the patient's bone was during insertion of other screws.At this time the distal end of the probe snapped off.He was able to easily recover broken fragment, but a small dural tear was created.He had to complete a dural repair with suture and fibrin sealant.Part number: 297-02-040, lot #: nw140086.Was it delayed? yes.How long? 20min.Action taken - dural repair - replacement of broken instrument.Was procedure completed? yes.Fragments: yes.Easily removed: yes.Patient "consequenses": unknown.Other medical intervention: dural repair.
Additional Manufacturer Narrative
(b)(4).Device was not returned for evaluation.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.Without the return of the device, we are unable to confirm the reported issue or identify the root cause.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.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: XPDM THORACIC PEDICLE PRB, CRV
• Common Device Name: PROBE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8267941
• Report Number: 1526439-2019-51263
• Device Sequence Number: 2202718
• Product Code: HXB
• UDI-Device Identifier: 10705034198446
• UDI-Public: (01)10705034198446
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2018

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: 279702040
• Device Catalogue Number: 279702040
• Device Lot Number: NW140086
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/31/2018
• Supplement Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 02/26/2019
• 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
• Patient Age: 62 YR
• Patient Weight: 115