MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7 LCKNG SCREW SLF-TPNG T8 SD REC 16; PLATE,FIXATION,BONE

Model Number	202.216
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2021, patient underwent a orif of a distal ulna procedure.The patient began having a heart attack, the surgeon was quickly able to get 6 screws in the plate before having to swiftly close the wound in order to transfer the patient to another hospital.It was noticed that the screw was too long, and the screw head stripped out and he was unable to change the screw.The surgery was completed successfully with no surgical delay.No patient consequences noted.This complaint involves two (2) devices.This report is for (1) 2.7 lckng screw slf-tpng t8 sd rec 16.This is report 1 of 2 or complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Patent identifier: mrn: (b)(6) additional product code: hwc ktt.Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Based on the information available, it has been determined that no corrective and 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: 2.7 LCKNG SCREW SLF-TPNG T8 SD REC 16
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12977679
• Report Number: 2939274-2021-07040
• Device Sequence Number: 4883913
• Product Code: HRS
• UDI-Device Identifier: 10886982143990
• UDI-Public: (01)10886982143990
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113364
• 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
• Report Date (Section B): 11/12/2021

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: 202.216
• Device Catalogue Number: 202.216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 12/10/2021
• 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: 2.7MM LCP(TM) PLATE 8 HOLES/76MM
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 59 KG