MAUDE Adverse Event Report: STRYKER TRAUMA KIEL REAMER SHAFT, MOD.TRINKLE BIXCUT Ø8X510 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 0227-8510S

Device Problems Residue After Decontamination (2325); Failure to Align (2522)

Patient Problems Nerve Damage (1979); Loss of Range of Motion (2032); Implant Pain (4561)

Event Date 04/21/2020

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient suffered a right tibia and fibula fracture from a dirt bike accident and on (b)(6) 2020 the plan was to remove a pilon plate that had been placed in the patient's leg ten years prior and repair the fracture with intramedullary nailing.A reamer was supposed to be used to go into the tibia and allegedly "both of our reamers had foreign material from former surgery" and therefore a "flexible intra reamer was then used to enter into the correct starting position.This flexible reamer did not follow the guide pin as hoped and made a small 6-8 mm hole on the anterior cortex of the tibia." allegedly he continues to suffer from knee pain, stiffness and tightness, possibility of compartment syndrome that may be causing his possible nerve injury.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported through the filing of a lawsuit that allegedly the patient suffered a right tibia and fibula fracture from a dirt bike accident and on (b)(6) 2020 the plan was to remove a pilon plate that had been placed in the patient's leg ten years prior and repair the fracture with intramedullary nailing.A reamer was supposed to be used to go into the tibia and allegedly "both of our reamers had foreign material from former surgery" and therefore a "flexible intra reamer was then used to enter into the correct starting position.This flexible reamer did not follow the guide pin as hoped and made a small 6-8 mm hole on the anterior cortex of the tibia." allegedly he continues to suffer from knee pain, stiffness and tightness, possibility of compartment syndrome that may be causing his possible nerve injury.

• Brand Name: REAMER SHAFT, MOD.TRINKLE BIXCUT Ø8X510 MM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 14469147
• MDR Text Key: 292360856
• Report Number: 0009610622-2022-00198
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 04546540722317
• UDI-Public: 04546540722317
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 0227-8510S
• Device Catalogue Number: 02278510S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male