MAUDE Adverse Event Report: MAKO SURGICAL CORP. TIBIAL, CHECKPOINT, STERILE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	111651
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Foreign Body In Patient (2687)
Date of Event	04/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
Event or Problem Description
The wound was closed while the tibial pin remained in the femur.I noticed by x-ray photography.Immediately after that, at the time of the operation on the opposite side, it was removed.Update: why was a tibial pin used in the patient¿s femur? please clarify or provide corrections as needed: the tibial pin was not used on the femur, it was left on the femur.Did the patient¿s wound have to be re-opened to remove the tibial pin? immediately after that, there was surgery on the other side, so they removed it.At what point was the x-ray taken when the pin was noticed still in the femur? after closing the wound.Did the patient come out of anesthesia between the side with the tibial pin remaining in the femur, and the start of the operation on the opposite site? unk.What side of the patient was the original side (the side with the reported tibial pin)?left please estimate any surgical delay, even if under a minute: unk.Were all pieces removed? yes, but the method is unknown.
Additional Manufacturer Narrative
Reported event: the wound was closed while the tibial pin remained in the femur.I noticed by x-ray photography.Immediately after that, at the time of the operation on the opposite side, it was removed.Update: why was a tibial pin used in the patient¿s femur? please clarify or provide corrections as needed: the tibial pin was not used on the femur, it was left on the femur.Did the patient¿s wound have to be re-opened to remove the tibial pin? immediately after that, there was surgery on the other side, so they removed it.At what point was the x-ray taken when the pin was noticed still in the femur? after closing the wound.Did the patient come out of anesthesia between the side with the tibial pin remaining in the femur, and the start of the operation on the opposite site? unk.What side of the patient was the original side (the side with the reported tibial pin)? left please estimate any surgical delay, even if under a minute: unk.Were all pieces removed? yes, but the method is unknown.Product evaluation and results: the alleged failure is not regarding the device failure.Also the reported event cannot be confirmed as there is no xray or other evidence provided.Product history review: product history review cannot be performed as lot no is not provided.Complaint history review: complaint history review cannot be performed as lot no is not provided.Conclusions: the alleged failure is not regarding the device failure.The checkpoint has been left inside by the surgeon and later removed, while our user guide states that the checkpoint should be removed before finishing up the surgery.No additional investigation or specific actions are required.If additional information is received, then the complaint will be reopened.H3 other text : device not returned.
Event or Problem Description
The wound was closed while the tibial pin remained in the femur.I noticed by x-ray photography.Immediately after that, at the time of the operation on the opposite side, it was removed.Update: why was a tibial pin used in the patient¿s femur? please clarify or provide corrections as needed: the tibial pin was not used on the femur, it was left on the femur.Did the patient¿s wound have to be re-opened to remove the tibial pin? immediately after that, there was surgery on the other side, so they removed it.At what point was the x-ray taken when the pin was noticed still in the femur? after closing the wound.Did the patient come out of anesthesia between the side with the tibial pin remaining in the femur, and the start of the operation on the opposite site? unk.What side of the patient was the original side (the side with the reported tibial pin)?left please estimate any surgical delay, even if under a minute: unk.Were all pieces removed?yes, but the method is unknown.

• Brand Name: TIBIAL, CHECKPOINT, STERILE
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 10038186
• Report Number: 3005985723-2020-00198
• Device Sequence Number: 2812691
• Product Code: OLO
• UDI-Device Identifier: 00848486001353
• UDI-Public: 00848486001353
• Combination Product (Y/N): N
• PMA/510(K) Number: K112507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

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 Model Number: 111651
• Device Catalogue Number: 111651
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 05/08/2020
• Supplement Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other