MAUDE Adverse Event Report: SYNTHES GMBH 2.7 METAPHYSEA SCR SLF-TPNG T8 SD REC/42; SCREW, FIXATION, BONE

Model Number	02.118.542
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Device-Device Incompatibility (2919); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).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.D2b.Additional pro-code: hrs.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 on (b)(6) 2023, a wear and possible metallic fragment broke off into the patient wound.The screw was unable to backed out by the t8 driver shaft, when exchanging for a longer screw.Intervention to remove metallic fragments was preformed.It was unknown if there was any surgical delay or patient consequences or if the procedure was completed successfully.This complaint involves one (1) device.This report is for one (1) 2.7 metaphysea scr slf-tpng t8 sd rec/42 this is report 1 of 1 for complaint (b)(4).
Event or Problem Description
Intervention to remove the metallic fragments was performed.There is a possibility that these fragments were also part of a needle driver from a hospital extras set that was used to grasp and attempt to extract the screw.This is report 1 of 2 for (b)(4).

• Brand Name: 2.7 METAPHYSEA SCR SLF-TPNG T8 SD REC/42
• 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: 16773003
• Report Number: 8030965-2023-04947
• Device Sequence Number: 16956969
• Product Code: HWC
• UDI-Device Identifier: 10886982039484
• UDI-Public: (01)10886982039484
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120854
• 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,Followup

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 Model Number: 02.118.542
• Device Catalogue Number: 02.118.542
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 04/26/2023
• 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: UNK - NEEDLE DRIVER.; UNK - SCREWDRIVERS.
• Patient Sex: Unknown