MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TROCHANTERIC GRIP; SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES

Catalog Number 3704-2-080

Device Problems Difficult to Remove (1528); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2015

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

The customer reported that as they opened up the dall miles implant, the scrub team noticed that the inner plastic packaging had adhered to the implant and couldn't be removed.They got another device from the tray and surgery was completed successfully.There were no delays to surgery as a result.The implant was for a left hip.The stryker sales representative was in the case.

Manufacturer Narrative

An event regarding a packaging issue involving a trochanteric grip plate was reported.The event was confirmed from the images provided.Methods & results: -visual inspection: the product was not returned however images were provided.It was confirmed from the images that the plastic was adhered to the device.-medical records received and evaluation: not performed as medical records were not received for evaluation and the device was not implanted.-device history review: device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other events for the lot referenced.Conclusions: it was reported that the device could not be removed from the packaging.It was confirmed from the images provided that the plastic was adhered to the device.Nc has been raised to investigate this event.Ncr has been raised by the supplier to investigate the event and to update the dcp.

Event Description

The customer reported that as they opened up the dall miles implant, the scrub team noticed that the inner plastic packaging had adhered to the implant and couldn't be removed.They got another device from the tray and surgery was completed successfully.There were no delays to surgery as a result.The implant was for a left hip.The stryker sales representative was in the case.

• Brand Name: TROCHANTERIC GRIP
• Type of Device: SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION APPLIANCES AND ACCESSORIES
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NA
• Manufacturer Contact: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5163695
• MDR Text Key: 29063218
• Report Number: 0002249697-2015-03425
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K070170
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/24/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: 3704-2-080
• Device Lot Number: G5634654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2015
• Initial Date FDA Received: 10/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2015
• 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