MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 14MM; SCREW, FIXATION, BONE

Model Number 02.200.014

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

Device report from denmark reports an event as follows: it was reported that on an unknown date, a patient experienced an allergic reaction caused by an implant in the ankle.No further information was provided.This report is for a 3.5mm stardrive cortex screw self-tapping 14mm.This is report 1 of 10 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional procode: hrs.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.

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.Product was not returned.Based on the information available, it has been determined that no corrective and 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.

• Brand Name: 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 14MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 15913973
• MDR Text Key: 304789924
• Report Number: 8030965-2022-10558
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982047809
• UDI-Public: (01)10886982047809
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K043185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.200.014
• Device Catalogue Number: 02.200.014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2022
• 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: CANCELLOUSSCR Ø4 FULL-THR L18 SST; CANCELLOUSSCR Ø4 FULL-THR L18 SST; CANCELLOUSSCR Ø4 FULL-THR L18 SST; CORTSCR Ø3.5 SELF-TAP L14 SST; CORTSCR Ø3.5 SELF-TAP L16 SST; CORTSCR Ø3.5 SELF-TAP L24 SST; CORTSCR Ø3.5 SELF-TAP L50 SST; CORTSCR Ø3.5 SELF-TAP L50 SST; LCP 1/3-TUB-PL 3.5 7HO L88 SST
• Patient Outcome(s): Other