MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INNER SHAFT W/STOP F/ACIS INSERT DEV; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 03.841.060

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Paralysis (1997)

Event Date 01/12/2022

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be 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.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

It was reported that on (b)(6) 2022, during an acdf c4/5 possible removal of existing plate, the surgeon was using acis set to implant an acis pro ti cervical graft.He inserted the implant and upon removal of the inserter realized it was in too far.He lost motors on the patient below the chest.(no equipment broke or malfunctioned).He then used a variety of instruments to try to remove the spacer which he was able to do.A new graft was placed and the plate was implanted with screws.Once the case was completed neuro monitoring showed that one side of her body was getting some motor response while the other side was not.There was a surgical delay when the graft had to be removed.This report is for one (1) inner shaft w/o stop f/acis insert dev.This is report 3 of 3 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: 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

It was reported that the patient was taken to the intensive care unit (icu) and had not progressed very well.

• Brand Name: INNER SHAFT W/STOP F/ACIS INSERT DEV
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13508353
• MDR Text Key: 285453672
• Report Number: 2939274-2022-00416
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10705034732404
• UDI-Public: (01)10705034732404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 03.841.060
• Device Catalogue Number: 03.841.060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ACIS IMPLANT INSERTER; INNER SHAFT W/O STOP F/ACIS INSERT DEV
• Patient Outcome(s): Required Intervention