MAUDE Adverse Event Report: ACUMED, LLC PRIMARY GUIDE ASSEMBLY; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number RBL2210

Device Problem Material Fragmentation (1261)

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

Event Date 09/07/2022

Event Type  malfunction  

Manufacturer Narrative

The returned ribloc primary guides were examined visually under magnification.All parts appeared clean without any defects or blemishes.Some mill marks could be seen on the inside of the holes, but there were no surface deformities.Functional testing was performed.All returned guides were able to pass pin gages within.001 of nominal values.A few parts would allow pin gages to go through partially and then "catch" partway through.Part diameters were measured using pin gages.All guides had at least one hole.001" out of range.All guides were tested with a demo drill bit and power source.All guides were able to allow the drill bit to pass through without binding or creating metal fragments as the reported event indicated.The slight deviation in tolerance should not effect the orientation of the drill bit in the hole.The drill bit must the inserted past the larger shaft transition in order to be oriented straight in the guide holes.It is also unclear where the chips/metal fragments were coming from as stated in the reported event.Based on the information received and the investigation performed, the root cause could not be determined.

Event Description

It was reported, during the procedure, metal fragments were found when removing the ribloc u plus primary guides (part number: rbl2210) from the surgical site.This happened two different times during the surgery.After troubleshooting all components, it was determined that the inside of the drill guides may have been nicked by the drill bit; however, at that time, it was not possible to confirm as it was tough to see.It was decided to remove all four (4) rbl2210 guides and replace with new guides.The procedure was completed, and it was reported there was no adverse consequences to the patient and no delay in procedure time.This report is related to report numbers: 3025141-2022-00333, 3025141-2022-00334, and 3025141-2022-00335 for the other primary guides involved in this event.

• Brand Name: PRIMARY GUIDE ASSEMBLY
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ACUMED, LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR 97124
• Manufacturer Contact: ellie wood ; 5885 ne cornelius pass road; hillsboro, OR 97124 ; 5035209618
• MDR Report Key: 15545266
• MDR Text Key: 306521437
• Report Number: 3025141-2022-00336
• Device Sequence Number: 1
• Product Code: LXH
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RBL2210
• Device Catalogue Number: RBL2210
• Device Lot Number: L1606011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2022
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1