MAUDE Adverse Event Report: SYNTHES PRODUKTIONS GMBH TIBIAL NAIL-ADVANCED / 9 345 / STERILE; SCREW, FIXATION, BONE

Model Number	04.043.135S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: jds.Complainant part is not expected to be returned for manufacturer review/ investigation.A device history record (dhr) review was conducted: device history lot - release to warehouse date: 28.05.2021, expiry date: 30.04.2031.A manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.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) 2021, the aiming arm of the tn-a missed the distal hole and had to free hand drill to insert the screw.Procedure was completed successfully with fifteen (15) minutes of surgical delay.Concomitant device reported: locking screw for medullary nails, low profile, 5 mm (part # 04.045.338; lot # unknown; quantity: 1), locking screw for medullary nails, low profile, 5 mm (part # 04.045.334; lot # unknown; quantity: 1), locking screw for medullary nails, low profile, 5 mm (part # 04.045.340; lot # unknown; quantity: 1) , unk - drill (part # unknown; lot # unknown; quantity: unknown).This report is for one (1) tibial nail-advanced / 9 345 / sterile.This is report 1 of 4 for complaint (b)(4).

• Brand Name: TIBIAL NAIL-ADVANCED / 9 345 / STERILE
• Common Device Name: SCREW, 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: 13060789
• Report Number: 9612488-2021-00016
• Device Sequence Number: 1427586
• Product Code: HWC
• UDI-Device Identifier: 10886982297631
• UDI-Public: (01)10886982297631
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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: 04.043.135S
• Device Catalogue Number: 04.043.135S
• Device Lot Number: 147P115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 12/22/2021
• 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: LOW PROF LCKNG SCR 5.0 / L 34 / XL25; LOW PROF LCKNG SCR 5.0 / L 38 / XL25; LOW PROF LCKNG SCR 5.0 / L 40 / XL25; TIBIAL NAIL-ADVANCED / 9 345 / STERILE; TIBIAL NAIL-ADVANCED / 9 345 / STERILE; UNK - DRILL BITS: TRAUMA; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM
• Patient Sex: Unknown