MAUDE Adverse Event Report: SYNTHES PRODUKTIONS GMBH TIBIAL NAIL-ADVANCED / 9 345 / STERILE; NAIL, 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	06/01/2022
Type of Reportable Event	Malfunction
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 product code: hwc.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 or Problem Description
Device report from synthes reports an event in the usa as follows: it was reported that on an unknown date of (b)(6) 2022, surgeon implanted a tibia nail advanced using a suprapatellar approach with the leg partially extended on a bone foam ramp positioner.3 interlock screws were implanted in the distal part of the nail then the nail was "backslapped" to reduce and compress the fracture.The proximal screw guide was attached and the static part of the oblong hole was drilled.The drill hit the nail superior and posterior to the screw hole and surgeon could not pass the drill through the nail.The drill and the drill guides were removed and reattached with a second attempt with the same result.We then attempted to drill the more proximal transverse static hole with the same result.The drill hit the nail and would not pass through the screw hole.After which the guide was removed and we used the "perfect circles" technique with x-ray to find and drill the path for the screws.It was unknown when was the issue observed.Patient consequences is unknown.Concomitant devices reported: unk - screws: nail proximal locking (part # unknown, lot # unknown, quantity # 3); unk - drill bits: trauma (part # unknown, lot # unknown, quantity # 1).This complaint involves one (1) device tibial nail-advanced / 9 345 / sterile.This is report 1 of 1 for complaint (b)(4).

• Brand Name: TIBIAL NAIL-ADVANCED / 9 345 / 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14852722
• Report Number: 9612488-2022-00021
• Device Sequence Number: 17329365
• Product Code: JDS
• UDI-Device Identifier: 10886982297631
• UDI-Public: (01)10886982297631
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2022
• Initial Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - DRILL BITS: TRAUMA; UNK - SCREWS: NAIL PROXIMAL LOCKING
• Patient Age: 30 YR
• Patient Sex: Male