MAUDE Adverse Event Report: MAKO SURGICAL CORP. BONE PIN, 3.2MM X 140MM, STERILE 2 PACK; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	213527
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of the 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
3.2 x 140 pin broke in half when dr.Was removing the pin.Case type: tka.Update: pin was being removed from femur when it broke.It was in the femoral array stabilizer.Both halves of bone pin removed.
Event or Problem Description
3.2 x 140 pin broke in half when dr.Was removing the pin.Case type: tka.Update: pin was being removed from femur when it broke.It was in the femoral array stabilizer.Both halves of bone pin removed.
Additional Manufacturer Narrative
Reported event: 3.2 x 140 pin broke in half when dr.Was removing the pin.Case type: tka.Product inspection: product inspection could not be performed as the product was not available for evaluation.Product history : review product history review did not reveal any results and product was not returned.Complaint history: review a review of complaints in catsweb and trackwise related to p/n 213527, lot number 48940618 shows 00 additional complaints related to the failure in this investigation n.Conclusion: the event could not be confirmed as the product was not returned for inspection.Nc/capa history review: corrective action/prev entive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.H3 other text : device not returned.

• Brand Name: BONE PIN, 3.2MM X 140MM, STERILE 2 PACK
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9260623
• Report Number: 3005985723-2019-00789
• Device Sequence Number: 19765731
• Product Code: OLO
• UDI-Device Identifier: 07613327412376
• UDI-Public: 07613327412376
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 213527
• Device Catalogue Number: 213527
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 02/13/2020
• 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