MAUDE Adverse Event Report: SYNTHES HAGENDORF CANNULATED CONNECTING SCREW FOR TIBIA INSERTION HANDLE; NAIL,FIXATION,BONE

Catalog Number 03.010.095

Device Problem Mechanical Jam (2983)

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

Event Date 02/24/2017

Event Type  malfunction  

Manufacturer Narrative

Patient's date of birth reported as (b)(6), exact date is unknown.Patient's weight reported as approximately (b)(6).Therapy date: the procedure started on the night of (b)(6) 2017 and carried into (b)(6) 2017.Device is an instrument and is not implanted/explanted.A device history record (dhr) review was performed on part # 03.010.095, lot# 8279966: manufacturing location: (b)(4), manufacturing date: 20 february 2013.No non conformance reports (ncrs) were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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 there were difficulties disengaging the cannulated connecting screws from the insertion handles twice.Patient underwent a tibia nail procedure on (b)(6) 2017 for a tibia shaft fracture.The procedure started on the night of (b)(6) 2017 and carried into (b)(6) 2017.The fracture was reduced.Using the aiming construct which consisted of an aiming arm, insertion handle, and connecting screw, a 9mm titanium (ti) cannulated tibial nail and two proximal 4.0mm ti locking screws were implanted.Upon attempting to remove the aiming construct, the connecting screw would not loosen from the insertion handle.The resident attempted to wiggle the nail to loosen it while the proximal locking screws were still implanted and was unsuccessful.Subsequently, the proximal locking screws and nail had to be completely removed.After removal, it was noted that the proximal end of the nail was bent.Surgery proceeded by using a new aiming construct that was available in the set.A new nail and one of the locking screws used during the first attempt was reused.After remeasuring and redrilling the hole during the second attempt, it was determined that the size of the other locking screw used during the first attempt would not fit therefore, a new 4.0mm proximal locking screw was inserted.There were no damages to that locking screw.Once the nail and two proximal locking screws were inserted, it was found that it was still difficult to disengage the connecting screw from the insertion handle.The patient¿s knee was bent to reduce the pressure and the aiming construct was successfully removed.Final intraoperative x-rays confirmed placement of the implants.There was an approximate 25 minutes surgical delay due the removing the first aiming construct and assembling a new one.Procedure was successfully completed without requiring medical interventions.Patient status/outcome was reported as stable.The connecting screws would not disengage from the nails twice.Based on the clarification, during the second attempt, by bending the patient's knee, the nail was successfully disengaged from the connecting screw and implanted.All aiming construct has been disassembled.Concomitant medical products: 4.0mm ti locking screw with t25 stardrive 38mm for intramedullary (im) nails (part# 04.005.428, lot# unknown, qty 1); 4.0mm ti locking screw with t25 stardrive 42mm for intramedullary (im) nails (part# 04.005.432, lot# unknown, qty 1); radiolucent insertion handle for expert nails/100mm (part# 03.010.486, lot# 830441, qty 1); aiming arm for ti cannulated tibial nails - expert (part# 03.010.052, lot# 8476581, qty 2); 9mm ti cannulated tibial nail - expert with proximal bend 345mm sterile (part# 04.034.349s, lot# unknown, qty 1); 4.0mm proximal locking screw (part# unknown, lot# unknown, qty 1); radiolucent insertion handle for expert tibia nails/23mm (part# 03.010.485, lot# 8344979, qty 1); 3.2mm guide wire 290mm (part# 03.010.115, lot# unknown, qty 1); 12.Mm cannulated drill bit large quick coupling (qc)/190mm (part# 03.010.036, lot# pe01968, qty 1).This is report 2 of 2 for complaint (b)(4).

Manufacturer Narrative

A product investigation was performed.The following parts were returned as concomitant devices without an alleged complaint condition.Upon visual inspection there is no evidence that these devices contributed to the complaint condition, and therefore no additional investigation will be performed on these devices.Part #: 03.010.486, lot #: 8304441 ,quantity: 1, part #: 03.010.485, lot #: 8344979, quantity: 1, part #: 03.010.036, lot #: pe01968, quantity, part #: 03.010.052, lot #: 8476581 quantity: 2.A visual inspection under 5x magnification, functional test, dimensional inspection of features related to this complaint, device history record (dhr) review and drawing review were performed as part of this investigation.All dimensions were measured.This complaint is confirmed for the returned nail.But this complaint condition was not able to be confirmed for the two returned connecting screws at customer quality (cq).Approximately one half of the proximal ledge of the returned nail has bent (peeled outward and torsionally twisted).Either leverage or pliers have caused the damage.The internal thread form shows wear but no thread damage that would impair function was observed when visually inspected under 5x magnification.Both returned connecting screws slid successfully through the returned concomitant insertion handles and threaded successfully into the returned nail.The connecting screws were able to be threaded and unthreaded easily at cq.Therefore, the complaint condition for the connecting screws exhibiting difficulty unthreading from the nail was unable to be replicated at cq with the returned devices.No new malfunctions were identified as a result of the investigation.Cannulated connecting screw for tibia insertion handle part #: 03.010.095, lot #: 8279966: the returned device shows wear marks and some discoloration of the threadform.The majority of the threadform is black with the exception of a few shiny areas.No damage that would impair function was observed when visually inspected under 5x magnification.The distal major thread diameter measured and found to be within specification per drawing.Relevant drawings were reviewed during this investigation.No product design issues or discrepancies were observed.Unable to replicate the complaint condition at cq and therefore a root cause cannot be determined.No new, unique or different patient harms were identified as a result of this evaluation.The returned parts were determined to be suitable for the intended use when employed and maintained as recommended.Lot number of concomitant device corrected.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

Concomitant devices reported: radiolucent insertion handle for expert nails/100 mm (part# 03.010.486, lot# 8304441, qty 1).

• Brand Name: CANNULATED CONNECTING SCREW FOR TIBIA INSERTION HANDLE
• Type of Device: NAIL,FIXATION,BONE
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6417340
• MDR Text Key: 70628167
• Report Number: 3003875359-2017-10133
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 10886982067654
• UDI-Public: (01)10886982067654(10)8279966
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040762
• 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
• Report Date: 02/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.095
• Device Lot Number: 8279966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2013
• 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
• Treatment: AIMING ARM, PART# 03.010.052, LOT 8476581, QTY 2; DRILL BIT, PART 03.010.036, LOT PE01968, QTY 1; GUIDE, PART 03.010.115, LOT UNKNOWN, QTY 1; INSERTION HANDLE PART 03.010.485, LOT 8344979 QTY1; INSERTION HANDLE PART 03.010.486, LOT 830441, QTY1; LOCKING SCREW, PART 04.005.428, LOT UNKNOWN, QTY 1; LOCKING SCREW, PART 04.005.432, LOT UNKNOWN, QTY 1; PROXIMAL LOCKING SCREW, PART & LOT UNKNOWN, QTY 1; TIBIAL NAIL, PART# 04.034.349S, LOT UNKNOWN, QTY 1
• Patient Age: 17 YR