MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HMRS HUMERUS HEX SOCKET BOLT; HUMEROUS IMPLANT

Catalog Number 64600007

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the product history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.The event involves a device that is not cleared for sale in the u.S., but similar device is commercially available in the u.S.A supplemental report will be submitted upon completion of the investigation.

Event Description

Our agent reported that during a humerous surgery it was found that none of the three bolts were equipped with the anti-rotational stop in plastic material located in the distal part of the screws and bolts of the hmrs system.Two bolts were implanted as programmed because they are fundamental to obtain the correct tightness of the implant.Only one connect screw with the intact anti-rotational stop was implanted.The other two pieces that were in the kit, were not implanted.

Manufacturer Narrative

An event regarding a missing component involving a hmrs bolt was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned, the device was implanted.Medical records received and evaluation: no medical records were received for review with a clinical consultant device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the reported lot.Conclusions: the device was not returned and therefore the event cannot be confirmed.The device was manufactured in 2016, was inspected and then distributed.Based on the information received it is known that the device has been sterilized on a number of occasions.Ifu ref # 0090-9-591 states the device should be double pouched in an appropriate packaging system or placed, unwrapped, in a rigid container system during sterilization.It is unknown if this occured.It is also unknown how the device was transported and stored between surgeries.The missing pellet was never previously identified at the central site in italy even through it been previously sterilized.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Our agent reported that during a humerus surgery it was found that none of the three bolts were equipped with the anti-rotational stop in plastic material located in the distal part of the screws and bolts of the hmrs system.Two bolts were implanted as programmed because they are fundamental to obtain the correct tightness of the implant.Only one connect screw with the intact anti-rotational stop was implanted.The other two pieces that were in the kit, were not implanted.

• Brand Name: HMRS HUMERUS HEX SOCKET BOLT
• Type of Device: HUMEROUS IMPLANT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-LIMERICK; raheen business park; limerick NA
• Manufacturer Contact: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7148650
• MDR Text Key: 96027848
• Report Number: 0002249697-2017-03707
• Device Sequence Number: 1
• Product Code: HTN
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2021
• Device Catalogue Number: 64600007
• Device Lot Number: CTD8384A
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2016
• 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