MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0 TI LCKNG SCREW T25 SD 44 F/IM NAIL-S; SCREW, FIXATION, BONE

Model Number	04.005.534S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: monument manufacturing date: january 28, 2021.Expiration date: december 31, 2029.Part number: 04.005.534s, 5.0mm ti locking screw w/t25 stardrive 44mm f/im nail-sterile.Lot number: 85p9448 (sterile).Two pieces were scrapped, final inspection, for an unacceptable surface finish ¿ dings/scratches.Production order traveler met all inspection acceptance criteria apart from the two pieces noted.Inspection sheet, inspect whirl threads, vibe, flute / final inspection, met all inspection acceptance criteria apart from the two pieces noted.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component(s) reviewed: component parts were not reviewed because the reported complaint condition of ¿removal due to cut-out and total hip conversion¿ does not indicate failure or breakage of the screw.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Product was not returned.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 (b)(4).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) 2022, the patient underwent a removal surgery of tfna due to cut out converted to total hip.The procedure successfully completed.The patient outcome is unknown.This report involves one (1) 5.0mm ti locking screw w/t25 stardrive 44mm f/im nail-ster.This is report 2 of 4 for (b)(4).
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: monument manufacturing date: january 28, 2021.Expiration date: december 31, 2029.Part number: 04.005.534s, 5.0mm ti locking screw w/t25 stardrive 44mm f/im nail-sterile.Lot number: 85p9448 (sterile).Two pieces were scrapped, final inspection, for an unacceptable surface finish ¿ dings/scratches.Production order traveler met all inspection acceptance criteria apart from the two pieces noted.Inspection sheet, inspect whirl threads, vibe, flute / final inspection, met all inspection acceptance criteria apart from the two pieces noted.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component(s) reviewed: component parts were not reviewed because the reported complaint condition of ¿removal due to cut-out and total hip conversion¿ does not indicate failure or breakage of the screw.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Product was not returned.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 (b)(4).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) 2022, the patient underwent a removal surgery of tfna due to cut out converted to total hip.The procedure successfully completed.The patient outcome is unknown.This report involves one (1) 5.0mm ti locking screw w/t25 stardrive 44mm f/im nail-ster.This is report 2 of 4 for (b)(4).

• Brand Name: 5.0 TI LCKNG SCREW T25 SD 44 F/IM NAIL-S
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13451643
• Report Number: 2939274-2022-00366
• Device Sequence Number: 4853703
• Product Code: HWC
• UDI-Device Identifier: 10886982086037
• UDI-Public: (01)10886982086037
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K000089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.005.534S
• Device Catalogue Number: 04.005.534S
• Device Lot Number: 85P9448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2021
• 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: 12/130 DEG TI CANN TFNA 380/RIGHT-SILE; 5.0 TI LCKNG SCREW T25 SD 38 F/IM NAIL-S; TFNA FENESTRATED HELICAL BLADE 95 - SILE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female