MAUDE Adverse Event Report: OSTEOMED, LLC MICRO SCREW 1.2MM X 6MM; SCREW, FIXATION, INTRAOSSEOUS

Model Number 204-1206

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/06/2022

Event Type  malfunction  

Event Description

It was reported that during a facial trauma procedure, the surgeon used the part number 204-1206 screws, and one of the following situations occurred: 1) the screw could not be inserted into bone, and then, the screw was broken or "was not straight" or 2) the screw was inserted into bone, and then, the screw was broken.It was reported predrilling was performed.There were no adverse consequences to the patient; however, it was reported this issue resulted in delay in procedure and fragment of the broken screw remains in the patient.It is unknown how many screws brokes broke/fragments remain in patient.The surgeon used 1.2mm screw with another length to complete the surgery.Information received indicated 14 screws from three different batch/lot numbers were involved.This report is related to the following report numbers for the other screws involved in this event: 2027754-2022-00012, 2027754-2022-00013, 2027754-2022-00014, 2027754-2022-00015, 2027754-2022-00016, 2027754-2022-00017, 2027754-2022-00018, 2027754-2022-00020, 2027754-2022-00021, 2027754-2022-00022, 2027754-2022-00023, 2027754-2022-00024, and 2027754-2022-00025.

Manufacturer Narrative

The results of the investigation are inconclusive as the device has not been received for evaluation.If the device is returned, a follow up report will be submitted upon completion of the investigation.

Manufacturer Narrative

The lot numbers for this event were reported as 1154827, 1157319, and 1160324, so the device history records (dhrs) were reviewed for these lot numbers.The review revealed all inspections passed, and no anomalies were noted.Six (6) screws were returned for evaluation.Additionally, fragments of broken screws were received.The six (6) screws were inspected by quality control (qc) personnel per the inspection plan.The results for each of the six (6) screws were as follows: one screw was observed to be unused and met all specifications.The second and third screws had cruciforms that showed signs of usage/exhibited wear and therefore did not meet specifications.The fourth, fifth, and sixth screws were only able to measured for the length but were unable to be measured for all other features due to significant damage to the cruciform, which is indicative of multiple failed attempts of insertion.A two year review of complaints indicated there have been two (2) complaints for this part family of screws; however, the complaint in this report is the only complaint received for "cannot be inserted into bone and screw was broken/not straight".Review of the instructions for use (ifu) revealed the following guidance is provided: use of an undersized plate or screw in areas of high functional stresses may lead to implant fracture and failure.Use of screws in high density bone may lead to implant fracture or failure upon insertion.Use of excessive torque during insertion of screws may lead to implant failure.All osteomed plates, screws, and instrumentation may be required for each surgery.Failure to use dedicated, unique osteomed instruments for every step of the implantation technique may compromise the integrity of the implanted device, leading to premature device failure and subsequent patient injury.Failed devices may require re-operation and removal.Carefully inspect the osteomed implants prior to use.Inspect the instruments before and after each procedure to assure they are in proper operating condition.Instruments which are faulty, damaged, or suspect should not be used.They should be replaced or sent to osteomed.The root cause of the reported event could not be determined based on the information provided and the investigation performed.Out of the six (6) devices returned, one (1) device which exhibited no signs of wear/usage met specification per the inspection plan while the five (5) remaining devices did not meet specification for one (1) or more features since damage to the cruciform was noted, which is indicative of multiple repeated/failed attempts of insertion; however, due to unknown procedural conditions, the cause could not be determined.

• Brand Name: MICRO SCREW 1.2MM X 6MM
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer (Section G): OSTEOMED, LLC; 3885 arapaho rd; addison TX 75001
• Manufacturer Contact: ellie wood ; 3885 arapaho rd; addison, TX 75001 ; 9726774600
• MDR Report Key: 14411309
• MDR Text Key: 292609340
• Report Number: 2027754-2022-00019
• Device Sequence Number: 1
• Product Code: DZL
• UDI-Device Identifier: 00845694000482
• UDI-Public: (01)00845694000482(10)1157319(30)1(11)210414
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K924138
• 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: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 204-1206
• Device Catalogue Number: 204-1206
• Device Lot Number: 1157319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Race: Asian