MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN 4MM X 140MM STERILE 2PK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number	144140
Medical Device Problem Codes	Positioning Failure (1158); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abdominal Pain (1685); Anemia (1706); Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135); Abdominal Distention (2601)
Date of Event	02/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported in "significant arterial injury by referencing pin placement in robotic-assisted total hip arthroplasty" the patient was a 61-year-old female patient who presented for elective left tha with the stryker mako robotic system for treatment of severe degenerative joint disease in the left hip.The patient was an overall healthy individual with her only significant past medical history being asthma and hypothyroidism.Her surgical history was significant for an uncomplicated right robotic-assisted tha.A standard posteriorly based approach to the hip was used after three percutaneously inserted 4 mm · 140 mm partially threaded pins were placed into the iliac crest.No complications with pin placement were appreciated intraoperatively.Approximately 1 hour after surgery, the patient developed hypotension unresponsive to fluids and phenylephrine.Her left hip examination was benign, dressings were dry, and the left lower extremity was neurovascularly intact distally.There was no evidence of periprosthetic fracture or dislocation on postoperative x-ray.The patient¿s only complaint at that time was abdominal pain and distension.A postoperative complete blood count demonstrated hemoglobin and hematocrit of 5.5 and 16.5, dramatically decreased from her preoperative values of 12.5 and 36.3, respectively.Transfusion of packed red blood cells (rbcs) and fresh frozen plasma (ffp) was initiated.A cta of the abdomen and pelvis demonstrated a large retroperitoneal hematoma with active bleeding in the region of the anterior superior iliac spine (asis).Vascular surgery and interventional radiology were immediately consulted, and the decision was made to proceed to interventional radiology for coiling vs.Embolization.Intraoperatively, an injury to the ascending branch of the deep iliac circumflex artery was identified and successfully coiled.The patient was admitted to the intensive care unit for monitoring.The remainder of her postoperative course was uneventful except for persistent postoperative anemia that required an additional 2 transfusions of rbcs.In total, the patient received 5 units of rbcs and 1 unit of ffp.Sequential compression devices and early ambulation were used for deep vein thrombosis prophylaxis.Chemoprophylaxis with aspirin 81 mg twice daily was initially withheld but initiated at the time of discharge on postoperative day 4.After discharge, the patient did well clinically, and there were no complications related to wound healing or to the ir procedure.The patient¿s only complaint was abdominal pain and fullness secondary to residual hematoma.These symptoms did not significantly limit her activities and gradually resolved over several months.At 1-year follow-up, x-rays remained benign and stable.The patient demonstrated painless hip range of motion to 100 of flexion, full extension, functional internal and external rotation, and no instability at 1-year follow-up.
Additional Manufacturer Narrative
Reported event: an event regarding incorrect placement - user error involving a mako tha software was reported.The event was confirmed.Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: the postoperative x-rays are routinely obtained to assess for, dislocation, periprosthetic femur or acetabular fracture and to a lesser degree leg length.No evidence for iliac perforation would be seen on these studies.Although not mentioned in the article it is likely the pelvic cta may have demonstrated the perforation but in light of the significant vascular findings was not mentioned and the actual cta report was not included in this case report.The vascular injury is totally consistent with perforation, but no specific documentation was provided.Product history review: could not be performed as the lot details were not provided.Complaint history review: could not be performed as the lot details were not provided.Conclusions: based on the clinician's review of additional documents provided, the alleged failure mode can be confirmed due to improper pin placement.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.
Event or Problem Description
No new information.

• Brand Name: BONE PIN 4MM X 140MM STERILE 2PK
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: deepan raju srinivasan ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23680481
• Report Number: 3005985723-2025-00560
• Device Sequence Number: 9846896
• Product Code: OLO
• UDI-Device Identifier: 00848486018177
• UDI-Public: 00848486018177
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K170584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 144140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female