MAUDE Adverse Event Report: 1303 GOSHEN SYNTHES USA PRODUCTS LLC 10 / TI CANN FRN / PF 400 / RIGHT - SILE; ROD, FIXATION, INTRAMEDULLARY

Model Number 04.033.040S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

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.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 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 (5) devices.This report is for (1) 10 / ti cann frn / pf 400 / right - sile.This report is 5 of 5 for (b)(4).

Event Description

The original date of the implant was on (b)(6) 2020.

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: 10 / TI CANN FRN / PF 400 / RIGHT - SILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): 1303 GOSHEN SYNTHES USA PRODUCTS LLC; 1303 goshen parkway; west chester PA 19380
• MDR Report Key: 12428631
• MDR Text Key: 271914876
• Report Number: 2530088-2021-00022
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982270832
• UDI-Public: (01)10886982270832
• Combination Product (y/n): N
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 04.033.040S
• Device Catalogue Number: 04.033.040S
• Device Lot Number: 3L49352
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 09/06/2021
• Supplement Dates Manufacturer Received: 10/05/2021
• Supplement Dates FDA Received: 10/05/2021
• Patient Sequence Number: 1
• Treatment: 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 SD 100; 6.5 TI RECON SCREW WITH T25 SD 100; 6.5 TI RECON SCREW WITH T25 SDDRIVE 95; 6.5 TI RECON SCREW WITH T25 SDDRIVE 95
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 71