MAUDE Adverse Event Report: STRYKER GMBH PILOT WIRE; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number 5901-1119

Device Problems Difficult to Remove (1528); Sticking (1597)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/06/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Guide pin became lodged in glenoid centering sleeve during operation and became un removable.

Manufacturer Narrative

Evaluation revealed the baseplate centering guide right and the pilot wire to be the subject products.No further associated products were reported.A review of the device history review for the baseplate centering guide revealed no discrepancies.The item was documented as faultless prior to distribution.As the item had been in use for approximately 2,5 years, we pre-suppose that the device had fulfilled its tasks in former surgeries as intended.A review of the device history review for the pilot wire could not be carried out as the lot code was unknown and not provided.A physical examination could not be carried out as the devices were not received for evaluation.Thus, a reasonable examination and investigation was not possible.Referring to the event description the pilot wire got jammed within the baseplate centering guide.Most likely the wire got cold welded due to friction based on bending forces during drilling the wire through the guide reception.This is a known reaction and already investigated in previous complaints.To guarantee a correct insertion it is necessary to insert the pilot wire through the guide with axial forces only; bending could lead to fretting and cold welding.The file will be closed formally in accordance to our procedures.In case the items and / or substantive information will become available in future the file will be reviewed and reopened.

Event Description

Guide pin became lodged in glenoid centering sleeve during operation and became un removable.

• Brand Name: PILOT WIRE
• Type of Device: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6755489
• MDR Text Key: 81525966
• Report Number: 0008031020-2017-00462
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5901-1119
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 76 YR