MAUDE Adverse Event Report: STRYKER TRAUMA KIEL IM REAMER, MOD. TRINKLE FITTING BIXCUT 11,0X480MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS

Model Number 0227-6110

Device Problem Break (1069)

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

Event Date 03/26/2021

Event Type  Injury  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.

Event Description

It was reported through medwatch mw5101338 that multiple graduated sized reamers are needed to prepare the intramedullary canal for receiving an orthopedic rod or nail.During a procedure to repair a left comminuted femoral shaft fracture, while reaming for the intramedullary nail, the flexible reamer broke in the femoral canal.The reamer was too flexible and would not rotate nor could be malleted out.The surgeon needed to take an alternate approach for retrieval.There was an increased length of time in the or in order to address the issue.The surgeon indicated a surgical delay of approximately 45 minutes.The patient, due to this event, did receive more anesthesia but from a clinical standpoint was hemodynamically stable.The broken part of the reamer was successfully retrieved from the patient.A new set of surgical reamers was obtained and the procedure was completed using a second entry site.

Manufacturer Narrative

D9 / h3 corrected to indicate device was returned.The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the shaft of the received reamer is broken.The inner spiral breakage ends are not in line to each other like the breakage ends of the outer spiral.This indicates that the inner spiral got constricted due to counterclockwise drilling.After the inner spiral was broken the part in the shaft sprang back to its usual position.The breakage surface shows the typical structure of a brittle fracture.The spirals are also slightly undone, and the entire instrument is badly deformed to such an extent that it must be replaced due to these irreparable damages.The cutting edges are also damaged / blunt and dent marks are visible on entire surface of spiral.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.The instructions for use instructs user that: ¿changes in mechanical, physical or chemical characteristics introduced under conditions of repeated use, cleaning and re-sterilization may compromise the integrity of the design and/or materials leading to diminished safety, performance and/or compliance with relevant specifications.Always treat the instrument carefully to avoid surface damage or alterations to the geometry.The design of the instrument must not be modified in any way.The stryker "instructions for cleaning, sterilization, inspection and maintenance" help to determine whether an instrument is in good condition or must be replaced due to excessive wear or obvious defects.¿ based on the investigation the root cause was attributed to a user related issue.The failure was caused due to an improper usage of the reamer as it was operated in an anti-clockwise manner which is an off-label use.Consequently, the spiral at the proximal part and middle of the of the reamer got wound up and bent.The cutting flutes of the reamers were also blunt hence the difficulty in reaming led unnecessary maneuver from the user to get the desired result.If any further information is provided, the complaint report will be updated.

Event Description

It was reported through medwatch mw5101338 that multiple graduated sized reamers are needed to prepare the intramedullary canal for receiving an orthopedic rod or nail.During a procedure to repair a left comminuted femoral shaft fracture, while reaming for the intramedullary nail, the flexible reamer broke in the femoral canal.The reamer was too flexible and would not rotate nor could be malleted out.The surgeon needed to take an alternate approach for retrieval.There was an increased length of time in the or in order to address the issue.The surgeon indicated a surgical delay of approximately 45 minutes.The patient, due to this event, did receive more anesthesia but from a clinical standpoint was hemodynamically stable.The broken part of the reamer was successfully retrieved from the patient.A new set of surgical reamers was obtained and the procedure was completed using a second entry site.

• Brand Name: IM REAMER, MOD. TRINKLE FITTING BIXCUT 11,0X480MM
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 12106492
• MDR Text Key: 259589503
• Report Number: 0009610622-2021-00585
• Device Sequence Number: 1
• Product Code: MAY
• UDI-Device Identifier: 04546540145864
• UDI-Public: 04546540145864
• Combination Product (y/n): N
• PMA/PMN Number: K153345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0227-6110
• Device Catalogue Number: 02276110
• Device Lot Number: K0EE9A2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention