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

Catalog Number	50382110
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported incident that the self-drilling half pin apex ø 3mm, 110 x 25mm was broken during surgery (s-11 / breakage during surgery) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.However, according to the reported event description, ¿the tip of pin broke off and was retained in patient¿s right tibia when inserting pin to be used for navigation tracker for right total knee.¿ please pay attention to what is clearly written in the op.Tech., that ¿apex pins are not intended for navigation procedure purposes.¿ since the 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.Please keep in mind what is mentioned in the ifu: ¿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.¿ based, on the above mentioned observation, the root cause was attributed to a user related issue, due to a mishandling of the device.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 any further information is provided, or if the device will be returned, the investigation report will be updated.Device will not be returned.
Event or Problem Description
Tip of pin broke off and was retained in patients right tibia when inserting pin to be used for navigation tracker for right total knee.No adverse patient events and no product to be returned per hospital policy.

• 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: 5869957
• Report Number: 0008031020-2016-00392
• Device Sequence Number: 528260
• Product Code: JDW
• UDI-Device Identifier: 07613327091748
• UDI-Public: (01)07613327091748(10)J32772
• 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
• Report Date (Section B): 07/15/2016

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: J32772
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2016
• Initial Report FDA Received Date: 08/11/2016
• 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: 62 YR
• Patient Weight: 102