MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 28MM F/IM NAIL-STER; SCREW, FIXATION, BONE

Model Number 04.005.518S

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

Patient Problems Unspecified Infection (1930); Inflammation (1932); Non-union Bone Fracture (2369); Swelling/ Edema (4577)

Event Date 01/01/2021

Event Type  Injury  

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.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 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 5.0mm ti locking screw w/t25 stardrive 28mm f/im nail-ster.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 9 of 11 for (b)(4).

• Brand Name: 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 28MM F/IM NAIL-STER
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16426035
• MDR Text Key: 310042203
• Report Number: 8030965-2023-02158
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982085870
• UDI-Public: (01)10886982085870
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.005.518S
• Device Catalogue Number: 04.005.518S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 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; RESRBLE SLV 5 ANGUL STBLE LCK SCR-S-2PK; RESRBLE SLV 5 ANGUL STBLE LCK SCR-S-2PK; TI END CAP T40 SD 0 EXT-S F/TI TIB NL
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female