MAUDE Adverse Event Report: SYNTHES USA FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK; REAMER

Catalog Number 351.16J

Device Problems Loose or Intermittent Connection (1371); Component Missing (2306)

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

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

The patient¿s date of birth is unknown; however, the patient is reportedly between (b)(6) years old.(b)(4).Device is an instrument and is not implanted or explanted.The complainant part is not expected to be returned for manufacturer review/investigation.(b)(6).Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the service history record review could not 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 the flexible shaft connector was loose and difficult to operate during an intramedullary nail exchange procedure of non-synthes implants on (b)(6) 2015.The scrub technician reportedly connected the 5.0mm flexible reamer shaft to the flexible shaft connector and noticed that the "knurled ring around the shaft connector" had come loose causing the device to rattle.The technician pushed the screw back in and continued on with the procedure.When the device was returned to the (original) hospital that owned the device, it was discovered that the chuck sleeve screw (a component that holds the flexible shaft connector in place) was missing.It is unknown when the chuck sleeve screw went missing.Although the flexible shaft connector will reportedly operate without the screw, it will be more difficult to utilize.The surgery during which this device was utilized was completed successfully with no surgical delay.However, it is uncertain whether or not the loose, and now missing, screw fragmented during the surgery.Standard intra-operative x-rays did not indicate any fragments or foreign objects.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Service history review: part no.351.16j, lot no: unknown: no service history review can be performed because the lot number is unknown and cannot be traced.The manufacture date is unknown.The service history evaluation is unconfirmed.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.

Manufacturer Narrative

Device was used for treatment, not diagnosis.A service and repair evaluation was performed for the subject device (5.0mm flexible shaft, part number 351.16j, lot number unknown).The repair technician reported that the chuck sleeve screw was missing and the item came apart.There was no visible lot number etch, the shaft was marked, and the chuck pin was damaged.¿missing parts¿ is the reason for repair.The item is not repairable.The cause of the issue is unknown.The evaluation was confirmed.A product development investigation was performed for the subject device.The flexible shaft connector (351.16j) is a component of the flexible reamer set which is utilized if reaming of the medullary canal is desired prior to the implantation of retrograde/antegrade femoral nails (r/afn), lateral femoral nails (lfn), and cannulated tibial nails.The photographs were examined and the complaint condition was confirmed as the connector was received disassembled; all components, with the exception of the set screw, were present.No definitive root cause was able to be determined as it is unclear when the screw was lost; the failure mode is consistent with misassembly following sterilization.Relevant drawings for the returned instrument were reviewed.The design, materials and finishing processes were found to be appropriate for the intended use of these devices.The failure mode is consistent with improper reassembly sterilization.The set screw is intended to align the knurled cap with an angled slot in the instrument body, allowing the release mechanism to function smoothly.Based on the complaint description, it is likely that the set screw was not aligned with the slot and therefore was not able to be fully threaded into the cap.This would allow the knurled cap to move unrestrained and rattle as described in the complaint description.The manufacturing drawing noted that loctite 243 was applied to the set screw in question; as such the instrument was not intended to be disassembled.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: FLEXIBLE SHAFT CONNECTOR FOR USE WITH JACOBS CHUCK
• Type of Device: REAMER
• 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: 5320593
• MDR Text Key: 34199944
• Report Number: 2520274-2015-18052
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 351.16J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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