MAUDE Adverse Event Report: SYNTHES MONUMENT CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE; GUIDE

Catalog Number 03.010.044

Device Problems Naturally Worn (2988); Device Handling Problem (3265)

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

Event Date 10/02/2015

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Unknown when device broke.Device is an instrument and is not implanted/explanted.Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system 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 a patient went to surgery for a broken proximal one-third (1/3) right femur.While the surgeon was using an insertion handle, the nodule on the handle broke off and caused the nail to rotate inside of the patient.The drill guide would not align with the holes in the nail, thereby, the surgeon had to free-hand to complete the procedure.There was a twenty minutes surgical delay due to trying to locate the nodule, which was not found inside or outside the patient.Additional x-rays were required which showed no nodule left inside the patient.It was harder for the surgeon to insert the nail and tough to extract the insertion bolt, also known as a cannulated connecting screw for standard insertion handle due to it appeared to have its' threads worn down or perhaps cross-threaded which made it difficult to disconnect.The procedure was completed without further incident.The patient status outcome is fine.This report is 2 of 4 for (b)(4).

Manufacturer Narrative

Device investigation summary ¿ the following device(s) were received: standard insertion handle (part # 03.010.045 | lot # 8935137); cannulated connecting screw (part # 03.010.044 | lot # p527231).The aiming arm was received with the alignment tang broken off.The tang was not received.The device has marks consistent with regular use and marks that are likely the result of errant hammer blows.The damage to alignment tang is likely the result of excessive torsional force being applied to the device to rotate the implanted nail coupled with wear.The connecting screw was tested at the complaint handling unit and no issues were observed.A visual inspection, functional test, and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.A review of the device history records has been requested.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

Additional manufacture date: june 21, 2005, september 30, 2015, december 19, 2005.Device history record review: part number: 03.010.044, supplier lot number: p527231: release to warehouse date: 27april2005.Supplier: (b)(4).Six synthes lots were produced from the supplier lot number p527231: lot 4996344 was rejected and returned to the supplier for shaft diameter that is undersize, for the thread out of specification, for inner diameter specification (some pieces too deep and some too shallow), and for the hex specification oversize.Lot 4996478 was released to warehouse on april 27, 2005.Lot 5015912 was released to warehouse on june 21, 2005.Lot 5015913 was rejected and returned to the supplier for rough surface finish for the visual specification.Lot 5072191 had one piece rejected and returned to the supplier for undersized outer diameter feature; the rest were released to warehouse on september 30, 2015.Lot 5131740 was released to warehouse on december 19, 2005.Some pieces were rejected for the tapered diameter shaft specification for the outer diameter feature.All rejections were designated to be used as is because the ¿weakest portion of screw (by design) is minor diameter of thread; non-conformance diameter is greater than minor diameter.¿ relevance to complaint condition cannot be determined until the product is returned for investigation.Review of the device history record(s) showed that there are potential issues during the manufacture of this product that would contribute to this complaint condition.A corrected product investigation was completed: the insertion handle was received with the alignment tang broken off.The tang was not received.The device has marks consistent with regular use and marks that are likely the result of errant hammer blows.The damage to alignment tang is likely the result of excessive torsional force being applied to the device to rotate the implanted nail coupled with wear.The connecting screw was tested at the complaint handling unit and no issues were observed.A visual inspection, functional test, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.The drawing for the device(s) was reviewed.No drawing issues or discrepancies were noted.The design is determined to be suitable for the intended use when employed and maintained as recommended.The cannulated connecting screw was tested with a known conforming nail available at the complaint handling unit (chu).The screw worked as designed with no difficulties or issues during insertion or removal.The complaint condition for the screw being difficult to remove/cross threaded is unconfirmed.The damage to alignment tang is likely the result of excessive torsional force being applied to the device to rotate the implanted nail coupled with wear.The design is adequate for its intended use when used and maintained as recommended, it did not contribute to the 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.

• Brand Name: CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE
• Type of Device: GUIDE
• 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: 5153043
• MDR Text Key: 28381266
• Report Number: 2520274-2015-16656
• Device Sequence Number: 1
• Product Code: FZX
• 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: 10/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.044
• Device Lot Number: P527231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2005
• 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
• Patient Age: 18 YR