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

Catalog Number 50382110

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/15/2016

Event Type  malfunction  

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 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
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5869957
• MDR Text Key: 52745417
• Report Number: 0008031020-2016-00392
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 07613327091748
• UDI-Public: (01)07613327091748(10)J32772
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K861766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50382110
• Device Lot Number: J32772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Weight: 102