MAUDE Adverse Event Report: ACUMED, LLC OLECRANON PLATE, STANDARD 7-HOLE RT; PLATE, FIXATION, BONE

Model Number 70-0307

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/06/2022

Event Type  Injury  

Event Description

It was reported the plate broke post-operatively two months after the initial implant procedure, and the plate and screws were explanted.No other information is available.This report is related to report number 3025141-2022-00206 for the screw involved in this event.

Manufacturer Narrative

The results of the investigation are inconclusive as the device was not returned for evaluation.Manufacturing and inspection records were reviewed and not anomalies were found.

Manufacturer Narrative

The following devices were returned for evaluation: part number 70-0307 "olecranon plate, standard 7-hole rt" batch number 515177 part number 30-0246 "3.5mm x 36mm locking hexalobe screw" batch number 523900 part number 30-0237 "3.5mm x 18mm locking hexalobe screw" batch number 524426 part number 30-0237 "3.5mm x 18mm locking hexalobe screw" batch number 524426 part number 30-0328 "2.7mm x 16mm locking hexalobe screw" batch number 520187 part number 30-0326 "2.7mm x 12mm locking hexalobe screw" batch number 520810 part number 30-0236 "3.5mm x 16mm locking hexalobe screw" batch number 514956 part number 30-0330 "2.7mm x 20mm locking hexalobe screw" batch number 471441 part number 30-0328 "2.7mm x 16mm locking hexalobe screw" batch number 540876 all items were returned in full.The returned parts were examined with magnified photography.The observed phenomena included: [olecranon plate batch 515177] anodization/coloration loss was noted on the underside of the plate by the breakage as well as in several threaded holes and compression slots; holes with anodization loss on the thread also had visible brown discoloration/corrosion.Surface scratching was prevalent.Breakage occurred through the second threaded shaft hole as measured from the cluster; breakage was roughly textured and jagged with no discernable flat/smooth fracture plane or necking/ductility.[36mm screw batch 523900] wear on and in the drive feature.[18mm screw batch 524426 2x] wear on and in the drive feature.Yellow debris present in trough/root of shaft threading; non-corrosive brown discoloration in the shaft threading; bone debris in locking thread.[16mm screw batch 520187] wear on and in the drive feature.[12mm screw batch 520810] wear on and in drive feature.Yellow/bony debris present in locking thread.[16mm screw batch 514956] wear on and in the drive feature.[20mm screw batch 471441] wear on and in the drive feature.[16mm screw batch 540876] wear on and in the drive feature.The returned plate had a highly textured surface indicating that the device failure may have been caused by sudden application of a large load.As the customer event includes no details other than "plate broke post operatively," (e.G.No event specifics, no info on patient physiology/weight, time since implant, patient activity level) the root cause of the reported event could not be determined.

• Brand Name: OLECRANON PLATE, STANDARD 7-HOLE RT
• Type of Device: PLATE, FIXATION, BONE
• 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: 14982015
• MDR Text Key: 295678635
• Report Number: 3025141-2022-00205
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K102998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 70-0307
• Device Catalogue Number: 70-0307
• Device Lot Number: 515177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2020
• 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): Other
• Patient Age: 73 YR
• Patient Sex: Male