MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NONRIM SPEED PIN 110 STERILE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	74013401
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	09/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).Competent authority report number: mw5145678.
Event or Problem Description
It was reported that, during surgery, while using the nonrim speed pin 110 sterile, its tip broke off into the patient's bone.The physician decided to leave the pin inside of the bone.It is unknown how long, if any, surgery was prolonged as consequence of the incident.It is also unknown what the current health status of the patient is.
Event or Problem Description
It was reported that, during surgery, while using the nonrim speed pin 110 sterile, its tip broke off into the patient's bone.The physician decided to leave the pin inside of the bone.It is unknown how long, if any, surgery was prolonged as consequence of the incident.The patient is doing well.No complication has been reported; next visit was scheduled for (b)(6) 2023.
Additional Manufacturer Narrative
Additional information in a1, a2, a3, a4, b5 and b7.
Additional Manufacturer Narrative
H3, h6.The device was not returned for evaluation; therefore, a device analysis could not be performed.However the provided analysis of the patient¿s x-rays of his tibia/fibula confirmed a small metallic fragment was noted in the anterior tibia.The clinical/medical investigation concluded that, based on the limited information provided, the definitive clinical root cause of the reported nonrim speed pin tip breakage could not be determined.The non-implantable nonrim speed pins are comprised of stainless steel, and they are manufactured and intended as externally communicating devices and are not approved for long-term internal tissue exposure and long-term implantation data is not available.Per the complaint, the surgeon decided to leave the nonrim speed pin tip inside of the patient¿s bone.Therefore, micro-motion and/or migration of the retained pin tip is unlikely.Although, we cannot make conclusions on the impact of the non-implantable foreign body.According to the report, the procedure was completed with the same device.However, it is unknown if there was a surgical delay.Of note, the patient is doing well, no complications were reported, and the patient was scheduled for a follow-up visit 10-10-2023.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 speedpins in caution section revealed that single use devices should not be reused due to risks of breakage.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.Based on the information provided, the unsatisfactory experience could be confirmed.At this time, we have no reason to suspect that the product failed to meet any specifications at the time of manufacture.This is a single use device, surgical technique or damage from misuse are likely potential factors that could contribute to the reported event.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.
Event or Problem Description
It was reported that, during a left tka w/wo patella resurfacing (left) surgery, while using the nonrim speed pin 110 sterile, its tip broke off into the patient's bone.The physician decided to leave the pin inside of the bone.It is unknown how long, if any, surgery was prolonged as consequence of the incident.The patient is doing well.No complication has been reported; next visit was scheduled for (b)(6) 2023.
Additional Manufacturer Narrative
H10.Additional information in b5, b7 and h6 (health effect - clinical code & health effect - impact code).

• Brand Name: NONRIM SPEED PIN 110 STERILE
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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: 17882591
• Report Number: 1020279-2023-01892
• Device Sequence Number: 6966275
• Product Code: HSX
• UDI-Device Identifier: 00885556071502
• UDI-Public: 00885556071502
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K113038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/06/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 74013401
• Device Lot Number: 21MNX0052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/12/2023; 11/29/2023; 11/30/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 10/12/2023; 12/05/2023; 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 84 KG