MAUDE Adverse Event Report: SYNTHES GMBH 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM; SCREW, FIXATION, BONE

Model Number	402.876
Medical Device Problem Codes	Break (1069); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from synthes reports an event in france as follows: the patient was hospitalized on (b)(6) 2022 for a fracture of the distal radius reduced by osteosynthesis.The exact implant date is unknown.The patient was re-examined after one month and presented with unscrewing of the implants placed as well as breakage of the 4 distal epiphyseal locking screws at the body-head junction in the absence of a fall.Additionally secondary displacement of the fracture site with extra-articular callus occurred.The material initially implanted was removed during a surgery revision on (b)(6) 2022 to rectify the callus and new osteosynthesis by plate.This is report 7 of 9 for (b)(4).This report is for a cortex screw.
Additional Manufacturer Narrative
Additional narrative: date of event: unknown event date.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter telephone (b)(6).(b)(4).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
The initial complaint was reviewed and found not reportable.It was further confirmed that there is no allegation against this device.

• Brand Name: 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15134395
• Report Number: 8030965-2022-05428
• Device Sequence Number: 20451595
• Product Code: HWC
• UDI-Device Identifier: 10886982206725
• UDI-Public: (01)10886982206725
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup

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 Model Number: 402.876
• Device Catalogue Number: 402.876
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 08/24/2022
• 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: CORTSCR Ø2.7 SELF-TAP L16 TAN; CORTSCR Ø2.7 SELF-TAP L16 TAN; CORTSCR Ø2.7 SELF-TAP L16 TAN; CORTSCR Ø2.7 SELF-TAP L16 TAN; CORTSCR Ø2.7 SELF-TAP L16 TAN; VA LOCKSCR Ø2.4 SELF-TAP L16 TAN; VA LOCKSCR Ø2.4 SELF-TAP L18 TAN; VA LOCKSCR Ø2.4 SELF-TAP L20 TAN; VA-LCP-2-COLUMN DRP2.4 VOLAR R SHAFT 2HO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown