MAUDE Adverse Event Report: STRYKER GMBH DRILL-TIP RECON K-WIRE IMN INSTRUMENTS Ø3.2X400MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2351-3240S
Medical Device Problem Codes	Break (1069); Fracture (1260); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "t2alphagt operation with recon mode.The patient's medullary cavity was narrow and we reamed the diaphysis 2mm over (nail used 10mm long 360mm).A drill tip guide wire was inserted distal to the recontour mode, but it did not go in well and had to be reinserted many times.It was found that the tip was broken when pulled out the guide wire all the way because it made a friction sound and creaked against the metal.After checking with c-arm, it turned out that it was still inside the nail.We attempted to remove the tip of guide wire by pulling out the nail halfway, but were unable to do so, so we pulled out the entire nail.The surgeon decided to leave the tip of guide wire inside the body because removing the tip would disrupt the current reconstruction.When the nail was reinserted, the tip moved to the distal side and finally stopped a little more proximal than the distal lateral screw (the most proximal position).'.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the k-wire was received in a broken state as reported.The broken tip was also returned for evaluation.Overall, the k-wire looked in a severely damaged condition.There were scuff marks present all over the surface of the k-wire, indicating heavy interaction most likely with the sleeve due to a possible inadequate insertion.The point of breakage shows severe plastic deformation.The fracture surface shows signs of a combination of ductile overload and brittle fracture, evident by permanent deformation along the edges and clear surface at the center.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause of the issue is deemed to be user related.The deformation signs and extent of damage indicates towards application of high torsional and bending load.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "t2alphagt operation with recon mode.The patient's medullary cavity was narrow and we reamed the diaphysis 2mm over (nail used 10mm long 360mm).A drill tip guide wire was inserted distal to the recontour mode, but it did not go in well and had to be reinserted many times.It was found that the tip was broken when pulled out the guide wire all the way because it made a friction sound and creaked against the metal.After checking with c-arm, it turned out that it was still inside the nail.We attempted to remove the tip of guide wire by pulling out the nail halfway, but were unable to do so, so we pulled out the entire nail.The surgeon decided to leave the tip of guide wire inside the body because removing the tip would disrupt the current reconstruction.When the nail was reinserted, the tip moved to the distal side and finally stopped a little more proximal than the distal lateral screw (the most proximal position).'.
Event or Problem Description
As reported: "t2alphagt operation with recon mode.The patient's medullary cavity was narrow and we reamed the diaphysis 2mm over (nail used 10mm long 360mm).A drill tip guide wire was inserted distal to the recontour mode, but it did not go in well and had to be reinserted many times.It was found that the tip was broken when pulled out the guide wire all the way because it made a friction sound and creaked against the metal.After checking with c-arm, it turned out that it was still inside the nail.We attempted to remove the tip of guide wire by pulling out the nail halfway, but were unable to do so, so we pulled out the entire nail.The surgeon decided to leave the tip of guide wire inside the body because removing the tip would disrupt the current reconstruction.When the nail was reinserted, the tip moved to the distal side and finally stopped a little more proximal than the distal lateral screw (the most proximal position).'.

• Brand Name: DRILL-TIP RECON K-WIRE IMN INSTRUMENTS Ø3.2X400MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 16703054
• Report Number: 0009610622-2023-00108
• Device Sequence Number: 3614345
• Product Code: LXH
• UDI-Device Identifier: 07613327361698
• UDI-Public: 07613327361698
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2023

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: 2351-3240S
• Device Catalogue Number: 23513240S
• Device Lot Number: K044D6C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 05/18/2023; 10/04/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 06/14/2023; 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2022
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown