MAUDE Adverse Event Report: SYNTHES PRODUKTIONS GMBH TIBIAL NAIL-ADVANCED / 12 360 / STERILE; NAIL, FIXATION, BONE

Model Number	04.043.440S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/ investigation.Part 04.043.440s, lot 179p269: release to warehouse date: june 25, 2021.Expiration date: may 31, 2031.Manufactured by: (b)(4).A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.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.
Event or Problem Description
It was reported that on (b)(6) 2022, the patient with a tibia shaft fracture was being treated with a suprapatellar tibial nail.During insertion of the tibial nail, the protection sleeve inner metal portion became delaminated from the plastic portion of the sleeve.This was identified prior to locking screw insertion.The nail was explanted, the pieces of the sleeve were removed, and the nail was reinserted.There were fifteen minutes surgical delay.The procedure was successfully completed.There was no patient consequence reported.This report is for a tibial nail.This is report 2 of 2 for (b)(4).

• Brand Name: TIBIAL NAIL-ADVANCED / 12 360 / STERILE
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES PRODUKTIONS GMBH; muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13561128
• Report Number: 9612488-2022-00004
• Device Sequence Number: 11837074
• Product Code: JDS
• UDI-Device Identifier: 10886982298096
• UDI-Public: (01)10886982298096
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K201336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.043.440S
• Device Catalogue Number: 04.043.440S
• Device Lot Number: 179P269
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2022
• Initial Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2021
• 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: PROTECTION SLEEVE F/NAILS Ø8-11 FLEX
• Patient Age: 34 YR
• Patient Sex: Female