MAUDE Adverse Event Report: SYNTHES GMBH 8.0MM/4.2MM DRILL SLEEVE 200MM; GUIDE, SURGICAL, INSTRUMENT

Model Number	03.010.065
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2022, during suprapatellar insertion of an advanced nailing system (ans), tibia nail advanced (tna) intramedullary nail, the surgeon was not able to put a 5.0mm interlock in the most distal proximal static interlock.This was the most distal of the proximal interlocks that are targeted through the aiming arm.They attempted to relieve from pressure on the system by placing a bump under the patient¿s knee, putting the knee into more of a flexed position but the long 4.2mm drill bit was still hitting the nail and not going through the interlock hole.They were eventually able to find the correct path by starting with a long 3.2mm drill bit, then drilling with the long 4.2mm drill bit.But when they went to insert the 5.0mm interlock the screw only made it through the near cortex and was spinning, likely contacting the nail or far cortex instead of passing through the drilled hole.They were not able to put an interlock through this hole and had to use a proximal oblique instead.Proximal targeted screw insertion through the aiming arm and long insertion handle was off.The drill bit was hitting the nail instead of going through the interlock hole in the nail.No surgical delay.There was no patient consequence.This report involves one 8.0mm/4.2mm drill sleeve 200mm.This is report 3 of 6 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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.

• Brand Name: 8.0MM/4.2MM DRILL SLEEVE 200MM
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15403002
• Report Number: 8030965-2022-06663
• Device Sequence Number: 12311561
• Product Code: FZX
• UDI-Device Identifier: 10886982067395
• UDI-Public: 10886982067395
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: 03.010.065
• Device Catalogue Number: 03.010.065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AIMING ARM/ RADIOLUCENT; DRILL SLEEVE / 4.2MM; INSERTION HANDLE/ RADIOLUCENT LONG; PROTECTION SLEEVE/ 11/8; UNK - NAILS: TIBIAL; UNK - SCREWS: NAIL PROXIMAL LOCKING
• Patient Sex: Unknown