MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 6.5 TI RECON SCREW WITH T25 SD 100; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.003.030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Event year is reported as 2021; however exact date of event is unknown.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 as no product was received.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
It was reported that on (b)(6) 2021, the patient underwent a hardware removal of the following: two titanium recon screw, two titanium locking screw and one femoral recon nail (frn), due to non-union of the femur right side.The original date of the implant was on (b)(6) 2021, all hardware was removed intact without complications.There were no implants broken and no fragments were generated.The patient was doing well post op.This complaint involves five (5) devices.This report is for (1) 6.5 ti recon screw with t25 sd 100.This report is 2 of 5 for (b)(4).
Event or Problem Description
The original date of the implant was on (b)(6) 2020.
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.H10 additional narrative: d10 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.B5 h5.

• Brand Name: 6.5 TI RECON SCREW WITH T25 SD 100
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12428625
• Report Number: 9612488-2021-00010
• Device Sequence Number: 17465972
• Product Code: HSB
• UDI-Device Identifier: 10886982081636
• UDI-Public: (01)10886982081636
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• 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: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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: 04.003.030
• Device Catalogue Number: 04.003.030
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 09/06/2021
• Supplement Report FDA Received Date: 10/05/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10 / TI CANN FRN / PF 400 / RIGHT - SILE; 10 / TI CANN FRN / PF 400 / RIGHT - SILE; 5.0 TI LCKNG SCR T25 SD 42 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 42 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 50 FOR IM NAILS; 5.0 TI LCKNG SCR T25 SD 50 FOR IM NAILS; 6.5 TI RECON SCREW WITH T25 SDDRIVE 95; 6.5 TI RECON SCREW WITH T25 SDDRIVE 95
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Weight: 71