MAUDE Adverse Event Report: STRYKER GMBH (MDR) SELF-DRILLING HALF PIN APEX Ø 3MM, 110 X 25MM; PLATE, FIXATION, BONE

Catalog Number 50382110

Device Problems Break (1069); Difficult to Remove (1528); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/07/2015

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

Surgeon was inserting two pins in distal femur.Both pins broke leaving the tips in the patients right femur.One in near cortex and one in the far cortex.They were not retrievable.

Manufacturer Narrative

The reported event that self drilling half pin apex had a breakage during surgery could be confirmed.The root cause of this breakage has been identified as a r&d/design issue.R&d maintenance took over this failure mode within the framework of a potential recurring situation identification board and reported the following: "the potential to improve the insertion behavior shall be investigated.Tolerance field of the tip is to be reduced.(b)(4) has been opened and will address this failure mode.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.If any further information is provided, the investigation report will be updated.

Event Description

Surgeon was inserting two pins in distal femur.Both pins broke leaving the tips in the patients right femur.One in near cortex and one in the far cortex.They were not retrievable.

• Brand Name: SELF-DRILLING HALF PIN APEX Ø 3MM, 110 X 25MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH (MDR); bohnackerweg 1; postfach; selzach 02545 ; SZ 02545
• Manufacturer (Section G): STRYKER TRAUMA KIEL (MDR); prof. kuentscher-strasse 1-5; postfach; schoenkirchen/kiel 24232 ; GM 24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4928424
• MDR Text Key: 22546177
• Report Number: 0008031020-2015-00318
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 50382110
• Device Lot Number: F34503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/24/2014
• 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: 60 YR
• Patient Weight: 98