MAUDE Adverse Event Report: DEPUY SPINE INC MOD LENKE PROBE ASSEMBLY

Catalog Number 698341387

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/27/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The 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 Description

It was reported that on (b)(6) 2019, during spinal fusion procedure the custom gear shift broke in the patient while cannulating ilium for pelvic screw.There was a surgical delay of fifteen (15) minutes.The procedure was successfully completed.Fragments were generated and were not removed easily.Patient status is unknown.Concomitant medical products: unknown pelvic screw (part# unknown, lot# unknown, quantity unknown).This complaint involves one (1) device.

Manufacturer Narrative

Product complaint (b)(4).Udi (b)(4).

Manufacturer Narrative

(b)(4).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.The mod lenke probe assembly was received with the device¿s distal tip broken approximately 35mm from its most distal point.There were clear shear marks on the fracture surface.No fragments were returned.The received condition was consistent with the complaint condition thus the complaint was confirmed.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.Although no definitive root-cause can be determined it is possible the device experienced unintended forces during use.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.

Manufacturer Narrative

Product complaint # (b)(4).Udi: (b)(4).Device was not returned for evaluation.However, images of the device were provided which confirmed the distal tip of the probe had broken from the main probe shaft.No fracture analysis could be performed without the return of the device.Therefore, the reported device failure is confirmed based on the evaluation of the picture of the device.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.Without the return of the device we are unable to 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, 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: MOD LENKE PROBE ASSEMBLY
• Type of Device: PROBE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9104538
• MDR Text Key: 163821915
• Report Number: 1526439-2019-52126
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 10705034477183
• UDI-Public: (01)10705034477183
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 698341387
• Device Lot Number: DP0914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Date Manufacturer Received: 11/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other