MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 95MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.038.195S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional product code: ktt.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 an unknown date, the patient underwent removal procedure due to broken tfna fenestrated screw.It was noted that the tfna lag screw broke inside a patient after healing.There was no broken fragment generated and no surgical delay.The procedure was successfully completed.Patient survived the procedure.This report is for a tfna lag screw.This is report 1 of 1 for (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.Part # 04.038.195s.Synthes lot # h638343.Supplier lot # n/a.Release to warehouse date: 07 jun2018.Manufactures by: elmira.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the tfna fenestrated screw 95 mm- sterile (p/n: 04.038.195s, lot #: h638343) was returned and received at us customer quality (cq).Upon visual inspection, the tfna fenestrated screw was observed to be broken at the distal end.Additionally, there were scratches and discoloration observed on the device.No other issues were identified with the returned device.Device failure/defect identified? yes.Dimensional inspection: dimensional inspection could not be performed due to the post-manufacturing damage and geometry of the device.Document/specification review: the current and manufactured revision of the following drawings were reviewed: ti tfna fenestrated screw complaint confirmed? yes.Investigation conclusion the complaint condition could be confirmed for the returned device as the returned device was observed to be broken.The broken device could have caused the complaint condition.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.

• Brand Name: TFNA FENESTRATED SCREW 95MM - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12246844
• Report Number: 2939274-2021-04314
• Device Sequence Number: 14152056
• Product Code: HSB
• UDI-Device Identifier: 10886982098757
• UDI-Public: (01)10886982098757
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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: 04.038.195S
• Device Catalogue Number: 04.038.195S
• Device Lot Number: H638343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 08/25/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: NAIL DISTAL LOCKING; UNK - SCREWS: NAIL DISTAL LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 125