MAUDE Adverse Event Report: STRYKER GMBH TIBIAL NAIL, STANDARD T2 TIBIA Ø10X330 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18221033S
Medical Device Problem Codes	Material Perforation (2205); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "during free hand distal drilling the drill removed titanium from the nail and elongated the hole.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device remains in patient body.
Event or Problem Description
As reported: "during free hand distal drilling the drill removed titanium from the nail and elongated the hole.".
Additional Manufacturer Narrative
Please note correction to section h6 (device code).This device is concomitant and did not contribute to the reported elongated hole.No allegation against the nail in original condition was confirmed and no adverse consequences reported.As per reported event the drilling was performed by free-hand technique and the operative technique clearly instructs the steps to be performed for freehand technique.Furthermore, the labelling t2 tibial nailing system instructs as following: ¿4.2 intra-operative.¿ avoid surface damage of implants.¿ discard all damaged or mishandled implants.¿.The reported event of drill contact to the metal implant during free-hand drilling could be confirmed since details available revealed evidence of damaged nail hole.Due to non-available device in question and counterpart nail used [as per details given ¿nail remained implanted¿] a physical inspection was impossible and further technical statement could not be given.An elongated nail hole could only be confirmed based on the image provided.However, the labelling clearly instructs not to use damaged or mishandled implants and to discard them.The individual steps for free-hand drilling are described in the corresponding operative technique in detail, which clearly points out: ¿the critical step with any freehand locking technique is to visualize a perfectly round locking hole with the c-arm.¿.Finally, based on details available an exact root cause could not be determined but since nothing was reported during pre-functional check, which is required per ifu, it could not be excluded that the event is rather related to a sub-optimal intraoperative procedure during free-hand drilling.¿.Complementary information about this event can be found under the main investigation for the drill.If any additional information is provided indicating otherwise the record will be reopened and the investigation will be reworked.

• Brand Name: TIBIAL NAIL, STANDARD T2 TIBIA Ø10X330 MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18073407
• Report Number: 0009610622-2023-00390
• Device Sequence Number: 15374625
• Product Code: HSB
• UDI-Device Identifier: 04546540197900
• UDI-Public: 04546540197900
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K003018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2024

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 Catalogue Number: 18221033S
• Device Lot Number: K0E8AD8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Male