MAUDE Adverse Event Report: DEPUY SPINE INC UNKNOWN KITS/SETS; MISC ORTHO SURGICAL INSTR

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Injury (2348); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown kits/sets/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to b.E returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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.(b)(4).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 Description

Device report from (b)(6) reports an event as follows: it was reported on an unknown date that the sets where delivered late after booking was made for a l5-s1 transforaminal lumbar interbody fusion (tlif) procedure.Stock of the vcffs screws was delivered incomplete after arrangement was made to transfer stock from another set that was not done.The transforaminal posterior atraumatic lumbar (t-pal) set was delivered without the applicator instruments which led to a fifteen (15) to twenty (2) minute surgical delay while the surgeon had to wait for instruments to be shipped to hospital.Upon arrival only the old applicator shaft was delivered and surgeon compromised the patient further and nicked the dura on insertion of the cage.This report is for one (1) unknown kits/sets.This is report 1 of 1 for (b)(4).

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.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 Description

Additional event information: surgical delay 15-20 minutes.This complaint involves eleven (11) devices.

• Brand Name: UNKNOWN KITS/SETS
• Type of Device: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10802370
• MDR Text Key: 215088976
• Report Number: 1526439-2020-02110
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention