MAUDE Adverse Event Report: SYNTHES GMBH TI END CAP W/T40 STRDRV 0MM EXT-STER F/TI TIBIAL NAILS-EX; NAIL, FIXATION, BONE

Model Number	04.004.000S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Inflammation (1932); Nonunion/Delayed-union Bone Fracture (2369); Swelling/ Edema (4577)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021 , the patient underwent incision & drainage and hardware removal after an mri without contrast of left knee and tibia/fibula on (b)(6) 2021 showed marrow edema within the posterior aspect of the left proximal tibia, concerning for osteomyelitis.Fluid collection measuring approximately 2.8 x 1.5 x 2.8cm was noted along the anterior aspect of the proximal tibial metaphysis, abutting the medially applied screw.Notable for extensive subcutaneous edema with associated myositis.All hardware was removed per orthopedics.This report involves one ti end cap w/t40 strdrv 0mm ext-ster f/ti tibial nails-ex.This pc is related to the following pcs: (b)(4)reports plate breakage of the same patient on an earlier date.(b)(4), (b)(4) report infection in the same patient at an earlier date.This is report 5 of 11 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: only the event year is known.Complainant part is not expected to be returned for manufacturer review/investigation.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.Device history lot part # 04.004.000s, synthes lot # 6981830, supplier lot # n/a, release to warehouse date: 08 oct 2012, manufactured by: (b)(4).No ncrs were generated during production.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.

• Brand Name: TI END CAP W/T40 STRDRV 0MM EXT-STER F/TI TIBIAL NAILS-EX
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16426048
• Report Number: 8030965-2023-02151
• Device Sequence Number: 5849466
• Product Code: JDS
• UDI-Device Identifier: 10886982083388
• UDI-Public: (01)10886982083388
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Other
• Initial Reporter Occupation: Other
• 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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.004.000S
• Device Catalogue Number: 04.004.000S
• Device Lot Number: 6981830
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2012
• 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: 10 TI CANNULATED TIBIAL NAIL-EX/315-SILE; 3.2MM GUIDE WIRE 400MM; 5.0 TI ANGUL STABLE LCKNG SCR T25 30 -S; 5.0 TI ANGUL STABLE LCKNG SCR T25 32 -S; 5.0 TI ANGUL STABLE LCKNG SCR T25 56 -S; 5.0 TI ANGUL STABLE LCKNG SCR T25 60 -S; 5.0 TI ANGUL STABLE LCKNG SCR T25 62 -S; 5.0 TI LCKNG SCREW T25 SD 28 F/IM NAIL-S; RESRBLE SLV 5 ANGUL STBLE LCK SCR-S-2PK; RESRBLE SLV 5 ANGUL STBLE LCK SCR-S-2PK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female