MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PILOT WIRE; INSTRUMENT

Catalog Number 5901-1119

Device Problems Entrapment of Device (1212); Mechanical Problem (1384); Difficult to Remove (1528); Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2015

Event Type  malfunction  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

(b)(6) was placing the reunion rsa pilot wire in the glenoid using the (l) deltopectoral kwire guide.The k-wire became welded in the kwire guide & he was unable to remove it.I had to open up another pilot wire and dr p.Placed it by freehand technique because the kwire was lodged in the pin guide and the tech was unable to remove it.We were unable to remove the pilot wire from the pin guide at our office and the 2 are still welded together.

Manufacturer Narrative

An event regarding a pilot wire stuck in the centering guide was reported.The event was confirmed.Method & results: -device evaluation and results: the returned device is still assembled into the centering guide.The pilot wire showed bent and galling and a fractured tip.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-device history review: all devices accepted into final stock conformed to specification.-complaint history review: there have been no similar previous reported events for this lot id.Conclusions: the investigation determined the likely root cause of the event could be the surgeon may not have inserted the pilot wire correctly at a 10 degree inferior tilt to the centering guide.Visual inspection of the returned pilot wire showed bent and galling confirming multiple attempts to insert it into the guide.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.

Event Description

Dr (b)(6) was placing the reunion rsa pilot wire in the glenoid using the (l) deltopectoral kwire guide.The k-wire became welded in the kwire guide & he was unable to remove it.I had to open up another pilot wire and dr (b)(6) placed it by freehand technique because the kwire was lodged in the pin guide and the tech was unable to remove it.We were unable to remove the pilot wire from the pin guide at our office and the 2 are still welded together.

• Brand Name: PILOT WIRE
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: william hanna ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5031371
• MDR Text Key: 25042970
• Report Number: 0002249697-2015-02788
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5901-1119
• Device Lot Number: SC15340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR