MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUP MED CLAV LK PL 6H L 73MM; PLATE, FIXATION, BONE

Model Number	71803411
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	01/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, after an intervention (ots of the left clavicle) with osteosynthesis material had been performed on (b)(6) 2022, the patient reported intense pain.An urgent x-ray indicates that the plate was released by the distal fragment, causing the need for a new intervention.Further details are unknown at the moment.
Additional Manufacturer Narrative
The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, no relevant clinical information has been provided for inclusion in this medical investigation.Therefore, a thorough medical investigation could not be rendered nor could the clinical root cause of the reported failure be determined.Per subsequent e-mail, the client reported, ¿according to the doctor, the patient¿s non-compliance led the reported failure.¿ the x-ray referenced in the complaint obtained due to the patient¿s complaint of severe pain indicated, ¿the plate was released by the distal fragment,¿ was not provided for review.Therefore, the impact to the patient beyond the reported loosening and the unknown new intervention cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this case would be re-assessed.A review of the manufacturing records 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 fracture fixation revealed that loosening of implant components has been identified as a possible adverse effect.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.Possible causes could include but not limited to traumatic injury, surgical technique or size of device.Possible causes could include but not limited to traumatic injury, surgical technique or size of device.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.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.

• Brand Name: SUP MED CLAV LK PL 6H L 73MM
• Common Device Name: PLATE, 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: 13591343
• Report Number: 1020279-2022-00847
• Device Sequence Number: 14907866
• Product Code: HRS
• UDI-Device Identifier: 03596010622631
• UDI-Public: 03596010622631
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K061352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2022

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 Model Number: 71803411
• Device Catalogue Number: 71803411
• Device Lot Number: 18JM10736
• 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: 02/04/2022
• Supplement Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 02/24/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 73824010-PERI-LOC 3.5MM T20 CRTX SCREW 10MM S-T; 73824012-PERI-LOC 3.5MM T20 CRTX SCREW 12MM S-T; 73824014-PERI-LOC 3.5MM T20 CRTX SCREW 14MM S-T
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male