MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TAN {} LIME {} 11.5X42 LF; NAIL, FIXATION, BONE

Model Number 71637342

Device Problems Break (1069); Fracture (1260); Product Quality Problem (1506)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/20/2022

Event Type  Injury  

Event Description

It was reported that during an internal fixation surgery for a sub-trochanteric fracture, when inserting the tan lime 11.5x42 lf in the patient's medullary canal, the drill bit went out of the nail hole and broke inside the patient.There was a delay of greater than 2 hours, while the end-user tried to remove the broken part, but it was difficult as it was in the neck of the femur.He had already spent a long time trying in s+n tan nail, so he decided to keep the broken part and finished using a competitor's device.No patient harm reported, the current health status is good, and the fracture has been healing well.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Event Description

It was reported that, during an internal fixation surgery for a sub-trochanteric fracture, the tan lime 11.5x42 lf was first attached to the drill guide before inserting it in the patient's leg; when attempting to insert the 6.4 mm drill bit, it passed and it was aligned.Then, when inserting the nail in the patient's medullary canal, the drill bit went out of the nail hole.The physician used the 3.2 tip threaded guide wire to check the trajectory of the hole.Insertion was attempted too many times, but the guidewire broke without passing through the hole.Surgery was delayed more than 2 h while the end-user tried to remove the broken part, but it was difficult as it was in the neck of the femur.He had already spent a long time trying in s+n tan nail, so he decided to keep the broken part inside and finished using a zimmer nail.The surgeon suspects of a problem with the neck of the tan lime 11.5x42 lf nail.The current health status is good, and the fracture has been healing well.

Manufacturer Narrative

Internal complaint reference number: (b)(4).

Event Description

It was reported that, during an internal fixation surgery for a sub-trochanteric fracture, the tan lime 11.5x42 lf was first attached to the drill guide before inserting it in the patient's leg; when attempting to insert the 6.4 mm drill bit, it passed and it was aligned.Then, when inserting the nail in the patient's medullary canal, the drill bit went out of the nail hole.The physician used the 3.2 tip threaded guide wire to check the trajectory of the hole.Insertion was attempted too many times, but the guidewire broke without passing through the hole.Surgery was delayed more than 2 h while the end-user tried to remove the broken part, but it was difficult as it was in the neck of the femur.He had already spent a long time trying in s+n tan nail, so he decided to keep the broken part inside and finished using a zimmer nail.The current health status is good, and the fracture has been healing well.

Manufacturer Narrative

Section h3, h6: the device was not returned for evaluation but the unlabeled fluoroscopy confirmed the location of a foreign body near the nail hole.The clinical/medical investigation concluded that, it¿s unknown where it was retained but it was reported that it was ¿in the neck of the femur¿.It¿s understood that the nail was replaced with a competitor nail.Although the surgeon suspected a problem with the neck of the femur, the dimensional evaluation confirmed, ¿all three holes passed alignment.¿ therefore, based on the information provided, we cannot rule out a procedural variance as the likely cause of the reported failure.Per the report, the 3.2 tip threaded guide wire comprised of 316 ss, was retained in the neck of the femur.The guide wires are manufactured and intended as externally communication devices and are not approved for long-term tissue exposure and long-term implantation data is not available.Since the device is retained in the neck of the femur, micro-motion/migration of the retained broken piece is unlikely.However, we cannot make conclusions on the impact of the non-implantable foreign body.Although, there was reportedly a surgical delay of greater than two-hours with prolonged use of anesthesia and a competitor¿s device was used to complete the procedure, there was no harm alleged to this patient.Based on the received report, the current health of the patient is good, and the fracture is healing well, no further clinical/medical assessment is warranted at this time.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This is a single use device, damage from misuse, excessive cleaning or rough handling are likely probable causes of the reported event.The contribution of the device to the reported event could be corroborated since the breakage of the guide caused a delay during the surgery.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.A visual inspection of the returned device did not confirm the stated failure mode.The device shows signs of use.A dimensional evaluation of the returned device could not confirm the stated failure mode.The device was found to be within tolerance.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.The clinical/medical evaluation concluded that single undated, unlabeled fluoroscopy confirmed the location of a foreign body near the nail hole at the time of the image.It¿s unknown where it was retained but it was reported that it was ¿in the neck of the femur¿.It¿s understood that the nail was replaced with a (zimmer) a competitor¿s nail.Although the surgeon suspected a problem with the neck of the nail, the dimensional evaluation confirmed, ¿all three holes passed alignment.¿ therefore, based on the information provided, we cannot rule out a procedural variance as the likely cause of the reported failure.Per the report, the 3.2 tip threaded guide wire is comprised of 316 ss, was retained in the neck of the femur.The guide wires are manufactured and intended as externally communication devices and are not approved for long-term tissue exposure and long-term implantation data is not available.Since the device is retained in the neck of the femur, micro-motion/migration of the retained broken piece is unlikely.However, we cannot make conclusions on the impact of the non-implantable foreign body.Although, there was reportedly a surgical delay of greater than two-hours with prolonged use of anesthesia and a competitor¿s device was used to complete the procedure, there was no harm alleged to this patient.Based on the received report, the current health of the patient is good, and the fracture is healing well, no further clinical/medical assessment is warranted at this time.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.The contribution of the device to the reported event could not be corroborated.Possible probable cause could include but not limited to the user error.This issue was evaluated through our internal quality process and it has been deemed no reason to suspect that the products failed to meet product specification at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TAN {} LIME {} 11.5X42 LF
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13498826
• MDR Text Key: 285345123
• Report Number: 1020279-2022-00599
• Device Sequence Number: 1
• Product Code: JDS
• UDI-Device Identifier: 03596010441225
• UDI-Public: 03596010441225
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K981529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71637342
• Device Catalogue Number: 71637342
• Device Lot Number: 14EM15528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 71631690, 3.2 TIP THREADED GUIDE WIRE, LOT UNKNOWN; 71637342, TAN LIME 11.5X42 LF, LOT 14EM15528
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 93 KG