MAUDE Adverse Event Report: STRYKER GMBH SELF-DRILLING HALF PIN APEX Ø 3MM, 110 X 25MM; PIN, FIXATION, THREADED

Catalog Number	50382110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Tip implanted in patient, remained retained by hospital.
Event or Problem Description
Primary procedure, right knee.It was reported that the tip of the self-drilling pin broke off in patient's right tibia during a navigated knee case.Surgeon elected to leave the tip in the patient's tibia with no surgical delay.Rep reported that no further information is available from the hospital or the surgeon.
Additional Manufacturer Narrative
The reported event that self-drilling half pin apex ø 3mm, 110 x 25mm was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by deviation from the operative technique and the instruction for use.It was reported that the pin was used for navigation purposes.As per op.Tech.(apex-st-1): ''apex pins are not intended for navigation procedure purposes.'' since the reported device was used for navigation, which is definitely a deviation from the specifications, the integrity could have been compromised and as a result the device broke.As per ifu (v15013): ¿ensure that you are familiar with the intended uses, indications/contraindications, compatibility and correct handling of the implant, which are described in the operative technique manual for the product system.Please remember that product systems may be subject to alterations that affect the compatibility of the implant with other implants or with instruments." a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Primary procedure, right knee.It was reported that the tip of the self-drilling pin broke off in patient's right tibia during a navigated knee case.Surgeon elected to leave the tip in the patient's tibia with no surgical delay.Rep reported that no further information is available from the hospital or the surgeon.

• Brand Name: SELF-DRILLING HALF PIN APEX Ø 3MM, 110 X 25MM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7929892
• Report Number: 0008031020-2018-00757
• Device Sequence Number: 2337891
• Product Code: JDW
• UDI-Device Identifier: 07613327091748
• UDI-Public: 07613327091748
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K861766
• 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): 12/12/2018

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 Catalogue Number: 50382110
• Device Lot Number: L53755
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 12/12/2018
• 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: 66 YR
• Patient Weight: 77