MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM CORTEX SCREW SELF-TAPPING 42MM; SCREW, FIXATION, BONE

Model Number	214.842
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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: d2: additional procode: ktt d9: complainant part is not expected to be returned for manufacturer review/investigation.D10: concomitant therapy date is (b)(6) 2023 h3, h4, h6: 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 or Problem Description
It was reported that the patient underwent a surgical procedure on (b)(6) 2023, where synthese stainless steel cannulated bone screws were used.During the procedure a number of synthese trauma products were implanted, including a hip plate, cortex screws and side screws.Post-surgery, the patient has been experiencing symptoms that lead them to believe they may be having an allergic reaction to the implanted items.No further information is available.This report is for a 4.5mm cortex screw self-tapping 42mm.This is report 2 of 7 for (b)(4).

• Brand Name: 4.5MM CORTEX SCREW SELF-TAPPING 42MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17299997
• Report Number: 8030965-2023-08598
• Device Sequence Number: 3784920
• Product Code: HWC
• UDI-Device Identifier: 10886982154705
• UDI-Public: (01)10886982154705
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161616
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 214.842
• Device Catalogue Number: 214.842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/17/2023
• Initial Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 38; 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 38; 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 44; 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 50; 5.0 LCKNG SCREW SLF-TPNG T25 SD REC 50; PEDIATRIC LCP COND PL 5.0/90/3 HOLES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female