MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK FIXATION PIN

Catalog Number UNK FIXATION PIN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/05/2023

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).D4-the device catalog number is unknown; therefore, udi is unavailable.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Revision of attune knee replacement, change of poly 5mm to 12mm.Fracture found distal femur, possible pin site fracture from due to velys pin but not confirmed.Did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? --> yes, did the patient require revision surgery or hardware removal? --> yes, facility name of original implant --> [hospital] , was device explanted? --> true, hardware/explant removal due to: --> pain, did patient require revision surgery? --> true, if yes, date of revision surgery.--> [date], reason for revision surgery.--> pain, if no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions?--> xray and bone scan , patient status/ outcome / consequences --> yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)?--> pain and fracture, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> yes, if yes, describe --> xray bone scan , is the patient part of a clinical study --> no, (b)(6).Device property of -->none, device in possession of -->none by checking this box i certify that all information that are known/available has been disclosed.If any new information will be made available, the additional information will be submitted through cst.--> true.

Manufacturer Narrative

Product complaint #(b)(4).Investigation summary: no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required product/lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history (lot): the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.

Event Description

Additional information received: a.Can you please clarify when was the pin site fracture issue identified? was it happened during primary procedure or post op? -during revision it was identified.B.Please confirm if the pin site fracture caused from velys pin.-yes.C.What was the effected side? left or right? -left.D.Please clarify if the femoral bone and/or femoral implant was fractured.-bone.

• Brand Name: UNK FIXATION PIN
• Type of Device: FIXATION PIN
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18328210
• MDR Text Key: 330549525
• Report Number: 1818910-2023-25366
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK FIXATION PIN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 12/22/2023
• Supplement Dates FDA Received: 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female