MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH CUP IMPACTOR BOLT; INSTRUMENT

Catalog Number 1440-2011

Device Problem Sticking (1597)

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

Event Date 07/29/2015

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that during a primary hip surgery 2 magnetic cup impactor tips got stuck inside 2 different cups of same part number.Surgical delay of approx 15 minutes to swap out the two cups which impactor tips got stuck in.

Manufacturer Narrative

An event regarding a disassembly issue for a cup impactor bolt from an associated shell was reported.The event was confirmed.A functional analysis confirmed that the cup impactor bolt could not be unscrewed by hand from the tritanium shell.Device history review indicated all devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated there have been no other similar events for the reported lot.

Event Description

It was reported that during a primary hip surgery 2 magnetic cup impactor tips got stuck inside 2 different cups of same part number.Surgical delay of approx 15 minutes to swap out the two cups which impactor tips got stuck in.

• Brand Name: CUP IMPACTOR BOLT
• Type of Device: INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-CORK; ida industrial estate; carrigtwohill NJ NA
• Manufacturer Contact: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5096407
• MDR Text Key: 26750245
• Report Number: 0002249697-2015-03127
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143085
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1440-2011
• Device Lot Number: DC232513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2014
• 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: 67 YR
• Patient Weight: 85