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 Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2019
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
Two of the 3.2mm x 140mm bone pins snapped off inside patient while drilling.Approx.1cm of the threaded part of the pin snapped off the first, approximately 4mm of the second.First pin snapped on i section, 2nd snapped on extraction.Case type: tka.16-30 minutes.
Event or Problem Description
Two of the 3.2mm x 140mm bone pins snapped off inside patient while drilling.Approx.1cm of the threaded part of the pin snapped off the first, approximately 4mm of the second.First pin snapped on i section, 2nd snapped on extraction.Case type: tka.16-30 minutes.
Additional Manufacturer Narrative
Reported event: two of the 3.2mm x 140mm bone pins snapped off inside patient while drilling.Approx.1cm of the threaded part of the pin snapped off the first, approximately 4mm of the second.First pin snapped on i section, 2nd snapped on extraction.Case type: tka.16-30 minutes.Product evaluation: 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 48470618, shows 00 additional complaints related to the failure in this investigation.Conclusion: the event could not be confirmed as the product was not returned for inspection.Corrective action/preventive 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: 9512808
• Report Number: 0002249697-2019-04089
• Device Sequence Number: 18929645
• Product Code: OLO
• UDI-Device Identifier: 07613327412376
• UDI-Public: 07613327412376
• Combination Product (Y/N): N
• 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): 02/25/2020

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: 48470618
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 02/25/2020
• 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
• Patient Age: 52 YR