MAUDE Adverse Event Report: SYNTHES USA 2.4MM CORTEX SCREW SELF-TAPPING/18MM; SCREW, FIXATION, BONE

Catalog Number 201.618

Device Problem Component Incompatible (1108)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: event date: unknown.(b)(4).No devices were implanted or explanted.Product investigation summary: all of the returned implants were received opened without their original packaging.The lot numbers for all implants are unknown.The returned implants had no discernible damage or marks on them, and all implants showed no signs of being used.Most of the returned implants had the smaller 3.5mm diameter head design and are part of the distal radius plate set; while part 201.637 had the 4.0mm diameter head design from the modular hand set.A visual inspection, dimensional inspection, and drawing review were performed as part of this investigation.All implants were determined to be conforming to specifications.The smaller screws were 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 modular hand set) was the root cause of the complaint condition.It is unknown why part # 201.637 was returned.This complaint is confirmed, but it is not due to a product design or discrepancy.The associated drawings for the device(s) 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 parts were determined to be suitable for their intended use when employed and maintained as recommended.The 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 associated technique guide.The 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 associated technique guide.Due to the difference in head size and head design/profile, the screws are not interchangeable.When restocking the modular hand set, the use of an inventory control form is recommended to ensure that the correct implants are ordered.As a result of not using one of these forms, the incorrect screws (3.5mm diameter head screws rather than ones with a 4.0mm head diameter) were ordered and stocked into the modular hand sets.Human/user error was the root cause of the complaint condition.The designs are adequate for their intended uses when used and maintained as recommended.Device history review: without a valid lot number, a review of the device history records cannot be requested.Device 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 an inspection of a 2.4mm modular hand set was conducted.It was identified that the set had been stocked by sterile processing personnel with the incorrect sized screws.The screws, which had all been removed from their original packaging, were the correct size and length, but did not have the correct head size.If used, the screw heads would not be large enough to hold the plates included in the modular hand set.Thirteen (13) of the screws that were unpackaged and stocked into the modular hand set were replaced with screws having the appropriate sized diameter heads.Between (b)(6) 2015, a total of eighteen (18) screws were received by the manufacturer related to this case.This report is 9 of 15 for (b)(4).

• Brand Name: 2.4MM CORTEX SCREW SELF-TAPPING/18MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5216545
• MDR Text Key: 30998676
• Report Number: 2520274-2015-17196
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 201.618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1