MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM CORTEX SCREW SELF-TAPPING 95MM; SCREW, FIXATION, BONE

Catalog Number	204.895
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2008, the patient had car/car collision and was admitted to the hospital.The patient underwent several surgeries for orthopedic injuries including an open reduction internal fixation for a fracture-dislocation of his femoral head and neck and a sacroiliac screw fixation and anterior pubic plate for malgaigne fracture.On (b)(6) 2008 the patient underwent orif left femoral head, orif left femoral neck, orif left anterior column acetabulum, orif pubic symphysis (synthes pelvic plate across his pubis extending to the left hip) and percutaneous iliosacral screw fixation due to left acetabular fracture and left femoral head fracture.On (b)(6) 2010 the patient underwent left total hip arthroplasty with depuy components due to hip pain, metallosis, traumatic arthritis left hip with femoral head avascular necrosis and nonunion femoral head fracture, malgaigne fracture and intraarticular hardware broke with screws.This report involves one (1) 3.5mm cortex screw self-tapping 95mm.This is report 1 of 10 for (b)(4).This product complaint is related to (b)(4).(b)(4) captures additional impacted products related to this event.
Additional 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.H10 additional narrative: d2b additional device product codes: hrs and jds.D9: complainant part is not expected to be returned for manufacturer review/investigation.D10 therapy date: (b)(6) 2008.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.

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 95MM
• 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: 17754878
• Report Number: 8030965-2023-11622
• Device Sequence Number: 12515241
• Product Code: HWC
• UDI-Device Identifier: 10886982146618
• UDI-Public: 10886982146618
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2010
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 204.895
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2023
• Initial Report FDA Received Date: 09/15/2023
• 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: 2.0 KIRSCHNER WIRE TROCAR POINT 150-10PK; 2.0 KIRSCHNER WIRE TROCAR POINT 150-10PK; 2.0 KIRSCHNER WIRE TROCAR POINT 150-10PK; 3.5MM CORTEX SCREW SELF-TAPPING 28MM; 3.5MM CORTEX SCREW SELF-TAPPING 32MM; 3.5MM CORTEX SCREW SELF-TAPPING 38MM; 7.3MM CANNULATED SCREW 32MM THREAD/90MM; WASHER 13.0MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male