MAUDE Adverse Event Report: SYNTHES GMBH 1.5 CORTEX SCREW SLF-TPNG T4 SD REC 14; PLATE, FIXATION, BONE

Catalog Number	02.214.114
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that (b)(6) 2023 the surgeon had issues with screws getting purchase in the bone.It's possible that there was a fragment there, however it was unknown.He decided to leave the third screw out because he felt comfortable with the fixation with two screws.Additionally when the first 1.1 drill bit was selected before use, it was determined to be bent.It was removed, and another drill bit was used successfully.The surgery was delayed for 5 minutes but it was successfully completed.No patient consequences was there.This report is for one (1) 1.5 cortex screw slf-tpng t4 sd rec 14.This is report 1 of 3 for complaint (b)(4).
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2b: additional product code: hwc.D9: complainant part is not expected to be returned for manufacturer review/investigation.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: 1.5 CORTEX SCREW SLF-TPNG T4 SD REC 14
• Common Device Name: PLATE, 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: 17836995
• Report Number: 8030965-2023-12312
• Device Sequence Number: 7456948
• Product Code: HRS
• UDI-Device Identifier: 10886982055484
• UDI-Public: (01)10886982055484
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 02.214.114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 09/28/2023
• 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: 1.1 DRILL BIT/K-WIRE ATTCHMT THRD H/70.; 2.0 CORTEX SCREW SLF-TPNG SD RECESS 13.; 2.0 CORTEX SCREW SLF-TPNG SD RECESS 14.
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 93 KG