MAUDE Adverse Event Report: STRYKER GMBH IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø8,0X480MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 0227-6080

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/31/2023

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported by the customer that: "when doing a tibial nail the reamer metal started to unravel while it was in the patients tibia.Surgeon able to slap it out with no apparent harm to the patient.".

Event Description

It was reported by the customer that: "when doing a tibial nail the reamer metal started to unravel while it was in the patients tibia.Surgeon able to slap it out with no apparent harm to the patient.".

Manufacturer Narrative

Correction - d3 (manufacturer entity), d9/h3, h3 (reason for no evaluation).The reported event could be confirmed, since one received image showed unraveled outer and inner spirals; at least the outer spiral was additionally broken off from the counterpart.The spiral was uncoiled in counterclockwise direction.Areas with reamer head resp with adapter connection were not shown.Spirals opened in counterclockwise direction had been operated in left-hand direction.The labeling prohibits turning to the left.If additional, substantive information or the item is provided the record will be reopened and the investigation will be re-assessed.The root cause was attributed as a user related issue.H3 other text : device disposition unknown.

• Brand Name: IM REAMER, MOD. TRINKLE FITTING BIXCUT Ø8,0X480MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• 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: 17241441
• MDR Text Key: 318342311
• Report Number: 0009610622-2023-00222
• Device Sequence Number: 1
• Product Code: MAY
• UDI-Device Identifier: 04546540145802
• UDI-Public: 04546540145802
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K123604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0227-6080
• Device Catalogue Number: 02276080
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1