MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM FOR IM NAILS; SCREW, FIXATION, BONE

Model Number	04.005.422
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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) 2021, the patient underwent removal of hardware and revision of tibia intramedullary (im) nail due to non-union.A screw was also broken prior to surgery on (b)(6) 2021.It is unknown when the screw broke.Original date of surgery was on april 22, 2020.The nail and screws were explanted successfully.The revision procedure was completed successfully without any complication or surgical delay.Patient status is unknown.This report is for one (1) 4.0mm ti locking screw w/t25 stardrive 32mm for im nails.This is report 1 of 5 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.H11 (corrected data): b1, b5, h1: the initial complaint was reviewed and found not reportable.The one (1) screw was broken prior to surgery on (b)(6) 2021.It is unknown when the screw broke.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.H11 (corrected data): b1, b5, h1: the initial complaint was reviewed and found not reportable.The one (1) screw was broken prior to surgery on (b)(6) 2021.It is unknown when the screw broke.

• Brand Name: 4.0MM TI LOCKING SCREW W/T25 STARDRIVE 32MM FOR IM NAILS
• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12571635
• Report Number: 2939274-2021-05898
• Device Sequence Number: 3322715
• Product Code: HWC
• UDI-Device Identifier: 10886982085344
• UDI-Public: (01)10886982085344
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K103002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 09/07/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.005.422
• Device Catalogue Number: 04.005.422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 11/07/2021
• 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: 4.0 TI LCKNG SCR T25 SD 40 FOR IM NAILS; 9 TI CANN TIBIAL NAIL-EX PROX BEND 390-S; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; 4.0 TI LCKNG SCR T25 SD 40 FOR IM NAILS; 9 TI CANN TIBIAL NAIL-EX PROX BEND 390-S; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 115 KG