MAUDE Adverse Event Report: SYNTHES GMBH 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 10MM; SCREW,FIXATION,BONE

Model Number	201.760
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code: hrs complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Reporter is a j&j representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient underwent for a surgery.During the surgery, it was noticed that the screw has a battered head and is not used in surgery.The needle is scratched at the tip.It was unknown if the surgery completed successfully.The patient outcome was unknown.This complaint involves two (2) devices.This report is for (1) 2.4mm cortex screw slf-tpng with t8 stardrive recess 10mm.This is report 1 of 1 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.H3, h6: product code: 201.760, lot #: 21p6434, manufacturing site: mezzovico, release to warehouse date: october 22, 2019.A manufacturing record evaluation was performed for the not sterile device lot number, and no non-conformances were identified.Investigation summary: the complaint device (2.4 cortex screw slf-tpng t8 sd rec 10) was not received for investigation.A photo investigation was performed.The images were reviewed, and the complaint condition is not confirmed.The device does not appear to have any defect, deformation or strips.As the physical device was not received, a functional test could not be performed and therefore it is impossible to know if the device is unable to be assembled.A definite assignable root cause could not be determined based on the provided information.As the device was not returned, and as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation no product design issues or discrepancies were observed (based on the images) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.
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.Device history lot - a manufacturing record evaluation was performed for the not sterile device lot number, and no non-conformances were identified.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: 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 10MM
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• 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: 12823697
• Report Number: 8030965-2021-09561
• Device Sequence Number: 17369889
• Product Code: HWC
• UDI-Device Identifier: 10886982142719
• UDI-Public: (01)10886982142719
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2021

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: 201.760
• Device Catalogue Number: 201.760
• Device Lot Number: 21P6434
• 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: 10/22/2021
• Supplement Date Received by Manufacturer: 11/16/2021; 01/19/2022
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 12/14/2021; 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2019
• 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: K-WIRE Ø1.6 L150 SST
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown