MAUDE Adverse Event Report: SYNTHES MONUMENT 2.4MM CORTEX SCREW SELF-TAPPING/12MM; SCREW, FIXATION, BONE

Catalog Number 201.612

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Manufacturing location: (b)(4).Manufacturing date: 22october2014.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported the screws were still in their original packaging and although the labeling was correct, the screws were noted to also have smaller diameter head; one that would slip through the hole in the plate.These three packaged screws with the wrong size head diameter were removed from the modular handset.These screws were not used on a patient.They were removed from the set and later replaced with appropriately sized screws.After an additional inspection of the modular hand set, it was ultimately confirmed that one loose screw and three unopened screws were found in the case.This is report 6 of 6 for (b)(4).

Manufacturer Narrative

Device investigation summary: the following device(s) were received: 2.4mm cortex screw, 3.5mm head (part # 201.612 | lot # 7832799).2.4mm cortex screw, 3.5mm head (part # 201.612 | lot # unknown).2.4mm cortex screw, 3.5mm head (part # 201.616 | lot # 7765254) - qty: 2.Three of the returned implants were received unopened, in their original packaging.The fourth implant was not in its original packaging.The returned implants had no discernible damage or marks on them and the one opened implant showed no signs of use.A visual inspection, dimensional inspection, complaint history review, and drawing review were performed as part of this investigation.The implants were determined to be conforming to specifications but incorrectly stocked into the 2.4mm modular hand set.These implants are designed with a 3.5mm diameter head rather than the required screws with a 4.0mm diameter head design.This difference in the head size/design could potentially cause the screws to slip through the plate holes.Per the complaint description, human error (not using inventory control form when restocking the set) was the root cause of the complaint condition.This complaint is confirmed, but it is not due to a product design or discrepancy.Device drawings were reviewed.No drawing issues or discrepancies were noted.The design is adequate for its intended use and did not contribute to this complaint condition.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.2.4mm cortex screws with 3.5mm head diameter design are part of the distal radius plate set and their recommended use is described in the technique guide.2.4mm cortex screws with 4.0mm head diameter design are part of the modular hand system and their recommended use is described in the technique guide.Due to the difference is head size and head design/profile, the screws are not interchangeable.Incorrect screws were ordered and the modular hand sets were stocked with 3.5mm diameter head screws rather than ones with a 4.0mm head diameter.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on an unknown date approximately one week prior to being reported, the wrong screws were inadvertently used to treat a fracture using a 2.4 limited contact dynamic compression plate (lcdc) surgery causing a fracture and a significant surgical delay.Reportedly screws with different head diameters were used; some with appropriate head diameters and some with the diameter of the screw heads were just fractionally small enough to be pulled through the plate hole with any force.It was the surgeon's assessment that this resulted in a new fracture of the metacarpal bone from the sheer forces caused by having part of the bone rigidly fixed and the rest of the bone being torqued away from it.It was reported during a meeting with the surgeon that a 3.4 mm modular handset, stocked by the sterile processing unit was stocked set with incorrect screws and the surgeon proceeded unknowingly to use the screws on the patient.Reportedly the surgeon was able to identify the correct screws stocked within the tray; he repaired the fracture and completed the surgery with at least a 30 minute delay.It is uncertain if any additional medical intervention was required while completing the procedure.Additional information: it was confirmed that the screw was ordered based on length which was correct, however the screw head size was ordered incorrectly.A retrospective inspection for other modular handsets was initiated and any like complaints will be documented and linked to this complaint.This report is 7 of 7 for (b)(6).

• Brand Name: 2.4MM CORTEX SCREW SELF-TAPPING/12MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5134226
• MDR Text Key: 27823330
• Report Number: 1719045-2015-10651
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201.612
• Device Lot Number: 7832799
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1