MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 390MM-STERILE; NAIL, FIXATION, BONE

Model Number	04.034.358S
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.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 (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.One fragment left in and retained in the patient and not retrieved.It is unknown when the screw broke.Original date of surgery was on (b)(6) 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) 9mm ti cann tibial nail-ex w/prox bend 390mm-sterile.This is report 3 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: 9MM TI CANN TIBIAL NAIL-EX W/PROX BEND 390MM-STERILE
• Common Device Name: NAIL, 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: 12571763
• Report Number: 2939274-2021-05900
• Device Sequence Number: 3322718
• Product Code: JDS
• UDI-Device Identifier: 10886982095145
• UDI-Public: (01)10886982095145
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• 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: 04.034.358S
• Device Catalogue Number: 04.034.358S
• Device Lot Number: H647027
• 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
• Date Device Manufactured: 05/29/2018
• 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 32 FOR IM NAILS; 4.0 TI LCKNG SCR T25 SD 40 FOR IM NAILS; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING; 4.0 TI LCKNG SCR T25 SD 32 FOR IM NAILS; 4.0 TI LCKNG SCR T25 SD 40 FOR IM NAILS; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 115 KG