MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACC 2.0MM COCR CABLE W/CLAMP; CERCLAGE, FIXATION

Catalog Number	71340007
Medical Device Problem Codes	Fracture (1260); Device Slipped (1584)
Health Effect - Clinical Codes	Erosion (1750); Bruise/Contusion (1754); Bone Fracture(s) (1870); Hip Fracture (2349); Insufficient Information (4580)
Date of Event	07/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during stem preparation in a thr surgery, a femoral fracture occurred while using a non-smith and nephew peter brehm stem, followed by one (1) acc 2.0mm cocr cable w/clamp slipping out of the clamp despite the torque lock as a consequence of the bone fracture.The procedure was resumed, after a significant delay, using a competitor¿s synthes cable device.A sample device slipped from the bone into the soft tissue causing potential injuries to muscle and to other non verifiable area since it was overlaid.Also, additional x-rays were used.No other complications have been reported as a result of this issue.
Additional Manufacturer Narrative
Internal reference number: (b)(4).
Additional Manufacturer Narrative
Updated results of investigation: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the provided photos appear to show one shorter portion with clamp of the severed cable and shows the longer piece of the cable with fraying on the end.It was communicated that the cable probably did not break during tensioning, but under the influence of force during the rasping process of the femoral stem preparation.The root cause of the event was most likely a result of force during the rasping process of the competitor femoral stem preparation as reported.The patient impact includes the severed cerclage cable secondary to ¿¿force during the rasping process of the femoral stem preparation¿¿ with use of competitor back-up device to resume procedure, and reported site complications including additional bone fracture, potential soft-tissue injuries, greater-than-30-minute surgical extension and additional imaging.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for cable systems/bands revealed in contraindications that physical conditions that would preclude adequate implant support or retard healing, blood supply limitations, insufficient quantity or quality of bone, previous infections, extensive soft tissue damage or damage directly adjacent to the implant site.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 evidence to conclude that the product failed to meet any specifications at the time of manufacture.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.
Additional Manufacturer Narrative
Additional information: d7a, h6 (component code, type of investigation, investigation findings, investigation conclusions), h8.Results of investigation: the device was not returned for evaluation; therefore, a device analysis could not be performed.The clinical/medical investigation concluded that, the provided photos appear to show one shorter portion with clamp of the severed cable and shows the longer piece of the cable with fraying on the end.It was communicated that the cable probably did not break during tensioning, but under the influence of force during the rasping process of the femoral stem preparation.The root cause of the event was most likely a result of force during the rasping process of the competitor femoral stem preparation as reported.The patient impact includes the severed cerclage cable secondary to ¿¿force during the rasping process of the femoral stem preparation¿¿ with use of competitor back-up device to resume procedure, and reported site complications including additional bone fracture, potential soft-tissue injuries, greater-than-30-minute surgical extension and additional imaging.A review of the production order did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.A review of the instructions for use documents for cable systems/bands revealed in contraindications that physical conditions that would preclude adequate implant support or retard healing, blood supply limitations, insufficient quantity or quality of bone, previous infections, extensive soft tissue damage or damage directly adjacent to the implant site.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 evidence to conclude that the product failed to meet any specifications at the time of manufacture.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.Corrected data: b5 (narrative), g2 (report source updated), h6 (health effect clinical code, medical device problem code).
Event or Problem Description
It was reported that, during stem preparation in a thr surgery, a femoral fracture occurred while using a non-smith and nephew peter brehm stem, followed by one (1) acc 2.0mm cocr cable w/clamp slipping out of the clamp despite the torque lock as a consequence of the bone fracture.The procedure was resumed, after a significant delay, using a competitor¿s synthes cable device.A sample device slipped from the bone into the soft tissue causing potential injuries to muscle and to other non verifiable area since it was overlaid.Also, additional x-rays were used.No other complications have been reported as a result of this issue, and the patient is in a good medical condition.

• Brand Name: ACC 2.0MM COCR CABLE W/CLAMP
• Common Device Name: CERCLAGE, FIXATION
• 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: 19935338
• Report Number: 1020279-2024-01534
• Device Sequence Number: 17362442
• Product Code: JDQ
• UDI-Device Identifier: 03596010485731
• UDI-Public: 03596010485731
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K031162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 71340007
• Device Lot Number: 22FSM0463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 11/01/2024; 11/04/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 11/01/2024; 11/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 100 KG