MAUDE Adverse Event Report: SYNTHES GMBH UNK - LOCKING/SET SCREWS: SYNAPSE; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Myocardial Infarction (1969)

Event Date 02/03/2022

Event Type  Death  

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2022, during the procedure the surgeon opened the "ocfusion" section, it was noticed that the locking nuts needed to fix the occipital plate were missing from kit.Other nuts were needed for the procedures.There was a surgical delay of twenty (20) minutes.After the surgery, upon awakening the patient had a heart attack and died.This report involves one (1) unknown locking/set screws: synapse.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

510k: this report is for an unknown locking/set screws: synapse/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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.Medical device problem code a27 used to capture device not available/missing.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.

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

It was further reported that the procedure was posterior cervical in nature.

• Brand Name: UNK - LOCKING/SET SCREWS: SYNAPSE
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13508319
• MDR Text Key: 285424990
• Report Number: 8030965-2022-00828
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - PLATES: OCCIPITAL
• Patient Outcome(s): Required Intervention; Death