MAUDE Adverse Event Report: STRYKER GMBH SELF-DRILLING HALF PIN APEX Ø 5MM, 200 X 50MM; PIN, FIXATION, THREADED

Model Number	5018-5-200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event that a self-drilling half pin apex ø 5mm, 200 x 50mm was alleged of breakage during surgery could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The reported lot number is invalid.It was asked to double-check it and the reply was that the lot number was not available (¿na¿).Following a search in our manufacturing database, it was found out that the most likely implant involved in this complaint is: catalog #: 50185200 product long description: self-drilling half pin apex ø 5mm, 200 x 50mm.Lot/serial #: (b)(4).Distribution data support this: the parts of lot# l14116 distributed to us were shipped on 30-may-2017 (reported event date: 18-jun-2017).Therefore, this investigation has been performed as if the actual device corresponded to the data above.Based on investigation, the root cause was attributed to a user or patient related issue.These are some of the possible causes: - the device was not handled correctly (e.G.Too high force applied, no notch for the pin created before pin insertion, wrong connection between implant and instrument) the device was damaged during the drilling or reaming process the device was damaged during storage and it was not inspected properly prior to surgery the device had been already used once, despite single-use high density of cortical bone 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.The instruction for use (v15013 rev n non active implant ifu ot-ifu-105 rev 3) was reviewed: ''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.[.] for your information, avail yourself of the training courses and publications offered (e.G.Operative techniques).[.] warning ¿ single use devices cannot be reused, as they are not designed to perform as intended after the first usage.Changes in mechanical, physical or chemical characteristics introduced under conditions of repeated use, cleaning and re-sterilization may compromise the integrity of the design and/or materials leading to diminished safety, performance and/or compliance with relevant specifications.Please refer to the device label to identify single or multiple use and/or cleaning and resterilization release.[¿] pre-operative ¿ the implant is for single use only.[.] ¿ inspection is recommended prior to surgery to determine if implants have been damaged during storage.[.] intra-operative ¿ avoid surface damage of implants.¿ discard all damaged or mishandled implants.¿ during the course of the operation, repeatedly check to ensure that the connection between the implant and the instrument, or between the instruments, required for precise positioning and fixing is secure.'' [original statement(s)] the cleaning and sterilization guide (ot-rg-1 rev 3_(b)(4)cleaning guide) was reviewed: ''6.Storage before use after sterilization, please store the medical devices in the sterilization packagings in a dry and dust-free place.The shelf life depends on the sterile barrier employed, storage manner, environmental and handling conditions.A maximum shelf life for sterilized medical devices before use should be defined by each health care facility.'' [original statement(s)] the operative technique (apex-st-1 en apex pins op tech) was reviewed: ''when using a self-drilling/self-tapping pin, turn the drill brace twice counterclockwise to create a small notch for the pin.This helps prevent the pin from slipping on the cortex.Afterwards, turn the drill brace clockwise for pin insertion.'' [original statement(s)] discarded by hospital.
Event or Problem Description
It was reported via fda report number (b)(4) that while reaming the left femoral shaft, the tip of a shantz pin broke off in the wound.The piece was not visible and was unable to be removed.The surgeon is aware and did not request any further intervention.Shantz pins are implantable but this pin was being used for intraop fixation.

• Brand Name: SELF-DRILLING HALF PIN APEX Ø 5MM, 200 X 50MM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 6788705
• Report Number: 0008031020-2017-00473
• Device Sequence Number: 137140
• Product Code: JDW
• UDI-Device Identifier: 07613327091960
• UDI-Public: (01)07613327091960(10)L14116
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K861766
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/11/2017

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: 5018-5-200
• Device Catalogue Number: 50185200
• Device Lot Number: L14116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2017
• Initial Report FDA Received Date: 08/11/2017
• 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: 58 YR