MAUDE Adverse Event Report: SYNTHES GMBH 3.5 LCKNG SCREW SLF-TPNG W/SD(TM) REC 50; NAIL, FIXATION, BONE

Model Number	212.121
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Impaired Healing (2378); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that around (b)(6) 2020 the patient fell from a scaffolding and injured his right knee.The ct scan revealed a comminuted bicondylar tibial plateau fracture.Around (b)(6) 2020 the patient underwent right tibial orif with medial posteromedial plating, medial and lateral meniscal repair and a prophylactic 4 compartment fasciotomy.The surgeon implanted a proximal anterolateral synthes tibial plateau locking plate and one 3.5 posteromedial tibial t plate with associated screws.The surgeon also utilized a single-use drill bit.Following the surgery of (b)(6) 2020 the patient performed rehabilitation and therapy as recommended by his medical providers.However, he continued to experience pain, discomfort, and functional limitations in his right knee.Also he experienced problems with wound healing, including increased pain, swelling, and drainage from the incision site.Around (b)(6) 2020 the patient diagnosed with septic arthritis.It was determined that the patient would undergo additional surgery for his wound complications, including arthroscopic irrigation and debridement of his medial and lateral incisions along with the removal of all his hardware and the installation of antibiotic cement into his screw holes.Around (b)(6) 2020 the surgeon performed extensive irrigation, debridement, antibiotic spacer placement, and removal of patient's surgical hardware.The surgeon also discovered a broken drill bit that had been retained from patient's (b)(6) 2020 surgery.The drill bit was a cause and source of patient's infection and inability to heal.The surgeon removed the broken drill bit.This complaint involves thirteen (13) devices.This report is for one (1) 3.5 lckng screw slf-tpng w/sd(tm) rec 50.This is report 7 of 14 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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: 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.
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.D10 therapy date: (b)(6) 2020.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.E3: initial reporter is attorney.

• Brand Name: 3.5 LCKNG SCREW SLF-TPNG W/SD(TM) REC 50
• Common Device Name: NAIL, 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: 16753157
• Report Number: 8030965-2023-04737
• Device Sequence Number: 8528274
• Product Code: JDS
• UDI-Device Identifier: 10886982151957
• UDI-Public: (01)10886982151957
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K072095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 212.121
• Device Catalogue Number: 212.121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 04/17/2023
• Supplement Report FDA Received Date: 10/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 3.5 LCKNG SCREW SLF-TPNG W/SD(TM) REC 55; 3.5 LCP T-PL 3H HD/ 5H SFT/74-OBLIQUE RT; 3.5 PELVIC CORTEX SCREW SELF-TAPPING 65; 3.5 VA LCKNG SCR SLF-TPNG/SD/75; 3.5 VA LCKNG SCR SLF-TPNG/SD/80; 3.5 VA PROX TIB PL SMALL BEND/4H/87/RT; 3.5MM CORTEX SCREW SELF-TAPPING 34MM; 3.5MM CORTEX SCREW SELF-TAPPING 36MM; 3.5MM CORTEX SCREW SELF-TAPPING 38MM; 3.5MM CORTEX SCREW SELF-TAPPING 50MM; 3.5MM CORTEX SCREW SELF-TAPPING 50MM; LCP ONE-THIRD TUBULAR PL COLLAR 6 H/69
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male