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

Model Number	279702010
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.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
Device report from (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2021, the tip of the awl broke off.The broken off distal part of the awl remained in the bone near the promontorium.A screw in a slightly higher convergence could be placed next to the broken off part of the awl without any problems.The procedure was successfully completed.Patient status is good.This report is for an expedium pedicle probe.This is report 1 of 1 for (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.D9 h3, h6: a review of the receiving inspection (ri) for xpdm pedicle probe, straight was conducted identifying that lot number nw212636 was released in two batches.Batch1: lot qty of (b)(4) units were released on 25 apr 2018 with no discrepancies.Batch2: lot qty of (b)(4) units were released on 25 apr 2018 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.Visual inspection: the xpdm pedicle probe, straight (p/n: 0279702010 lot: nw212636) was received at west chester customer quality.A visual inspection of the device showed that the probe head was broken off.The broken off piece was not returned.An inspection of the photo confirmed the embedded piece in the patient.No other issues were noted with the device.Device failure/defect identified? yes.Dimensional inspection: no dimensional inspection was performed on the complaint device due to post-manufacturing damage.Document/specification review: the following revisions of the product drawings were reviewed: (current and manufactured) complaint confirmed? yes.Conclusion: the complaint condition is confirmed for the received device as the probe head is broken and the piece is embedded in the patient.During investigation no manufacturing or design discrepancies were identified.A definitive assignable root cause cannot be determined from the provided information.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: XPDM PEDICLE PROBE, STRAIGHT
• Common Device Name: PROBE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12468033
• Report Number: 1526439-2021-01990
• Device Sequence Number: 4892416
• Product Code: HXB
• UDI-Device Identifier: 10705034198415
• UDI-Public: (01)10705034198415
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: NW212636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 10/18/2021
• 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