MAUDE Adverse Event Report: SYNTHES GMBH WASHER FOR NUT 17.5/11.8MM STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.045.782S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6), 2022 the patient sustained injuries as a result of trip and fall over a security band on the exterior sidewalk premises of the store.After a mechanical fall from standing, imaging showed right distal femur fracture and left proximal humerus fracture.On (b)(6), 2022 the patient underwent imn of right femur.Open reduction internal fixation (orif) of left humerus fracture on (b)(6), 2022.He was discharged to for acute rehab on (b)(6), 2022.On (b)(6), 2023 the patient was admitted for right femur nonunion revision, with worsening right thigh pain and impaired mobility.The patient had antibiotic management of right femoral osteomyelitis.This report is for a washer for nut 17.5/11.8mm sterile 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.B3: unknown event date between (b)(6), 2022-(b)(6), 2023.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.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.

• Brand Name: WASHER FOR NUT 17.5/11.8MM STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 17548311
• Report Number: 8030965-2023-10295
• Device Sequence Number: 12428570
• Product Code: HSB
• UDI-Device Identifier: 10886982296115
• UDI-Public: (01)10886982296115
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K201346
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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 Catalogue Number: 04.045.782S
• Device Lot Number: 132P530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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: 2.5 REAMING ROD BALL TIP/950-STERILE; 3.2MM GUIDE WIRE 400MM; 4.2 3-FLTD DRILL BIT QC/NEEDLE PT/145-S; 4.2 3-FLTD DRILL BIT QC/NEEDLE PT/145-S; DRILL BIT/ CALIBRATED/ 4.2 EXTRA-LONG; LCKNG SCREW FOR IM NAIL 5/ 100/ XL25; LOCKING SCREW FOR IM NAIL 5/ 40/ XL25; LOCKING SCREW FOR IM NAIL 5/ 42/ XL25; LOCKING SCREW FOR IM NAIL 5/ 44/ XL25; LOCKING SCREW FOR IM NAIL 5/ 68/ XL25; LOCKING SCREW FOR IM NAIL 5/ 90/ XL25; NUT 14MM STERILE; NUT 14MM STERILE; RFNA/ 12MM/ 420MM/ STANDARD BEND/ STER; UNK - DRILL BITS: TRAUMA; UNK - SCREWS: NAIL DISTAL LOCKING; WASHER FOR NUT 17.5/11.8MM STERILE; WASHER FOR NUT 17.5/11.8MM STERILE; WASHER FOR SCREW 14/7MM STERILE; WASHER FOR SCREW 14/7MM STERILE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male