MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MIS 3.2MM X 45MM RIMMED PIN STERILE; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	74016465
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during tka surgery, the tip of a mis 3.2mm x 45mm rimmed pin sterile broke off while drilling into a 4/1 femoral cutting block.The doctor did not want to go digging into the condyle to retrieve it so he left half of the pin embedded into the condyle.The procedure was resumed, without any delay, using the same device.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the associated device was returned and evaluated.The visual inspection revealed 3 pins were returned and 1 is broken.The broken piece of the pin was not returned.The clinical/medical investigation concluded that, this case reports a tip breakage of a mis 3.2mm x 45mm rimmed pin sterile broke off while drilling into a 4/1 femoral cutting block that was not recovered from inside of the patient.According to the report, the surgeon did not want to go digging into the condyle to retrieve it, so it was reported surgeon left half of the pin embedded into the condyle.No clinically relevant supporting documentation was provided for inclusion in this medical investigation.Therefore, the root cause of the reported pin tip breakage could not be determined.The mis 3.2mm x 45mm rimmed pin sterile is comprised of stainless steel, 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 report, the pin tip is retained in the condyle with is bone, therefore, the potential for micro-motion/migration of the broken tip is unlikely.However, we cannot make conclusions on the impact of the non-implantable foreign body.It was reported the procedure was completed without a delay, using the same device.Since no other complications were reported and no further harm is anticipated, no further clinical/medical assessment is warranted at this time.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 speed pins revealed that the speed pin should be aligned with the orientation of the instrument fixation hole and should touch the bone before drilling to avoid pin binding in the block.Also, using a mallet with speed pins must be avoided, as speed pins can bend and bind in blocks.The review of speed pins also revealed that single use devices should not be reused due to risks of breakage, this has been identified as a caution.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 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 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.

• Brand Name: MIS 3.2MM X 45MM RIMMED PIN 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: 16415093
• Report Number: 1020279-2023-00383
• Device Sequence Number: 19709049
• Product Code: HSX
• UDI-Device Identifier: 00885556691984
• UDI-Public: 885556691984
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K113038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2023

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: 74016465
• Device Lot Number: 20LNX0044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2023
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2021
• 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: Required Intervention
• Patient Sex: Unknown