MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS 44MM PROXIMAL HUMERAL HEAD; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	64875044
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.
Event or Problem Description
As reported: "during the case, the implant box was taken out of the tub for use.The outer wrapping was intact and the box appeared in good condition.When the sterile pack holding the implant was pulled out of the box to implant, the sterile package was visually broken and the paper inside was unsealed.The implant was not used and sterilized for return to warehouse to initiate the per for packaging.".
Event or Problem Description
As reported: "during the case, the implant box was taken out of the tub for use.The outer wrapping was intact and the box appeared in good condition.When the sterile pack holding the implant was pulled out of the box to implant, the sterile package was visually broken and the paper inside was unsealed.The implant was not used and sterilized for return to warehouse to initiate the per for packaging.".
Additional Manufacturer Narrative
Reported event; an event regarding pack damage involving a mrs head was reported.The event was confirmed through visual inspection of the returned device.Method & results: product evaluation and results: one unit carton with shrink wrap and an national loaner west label was returned for evaluation.The shrink wrap was opened on one end.Damage and multiple indentation lines are visible on the unit carton.The outer blister with the inner blister place inside it was inside the unit carton.The device (mrs head) was loose in the unit carton.The outer blister was returned with the tyvek lid remaining attached on one side to the blister.One side flange was cracked/broken away from the outer blister.The flange remains attached to the tyvek lid.There is evidence of a good seal on the three sides of the blister.Dark foreign matter/substance what appears to be blood is visible on the tyvek lid.The inner blister was returned inside the outer blister with the tyvek lid attached on one side.There is evidence of a good seal on the inner blister.Dark foreign matter/substance is visible on the tyvek lid of the inner blister.Scuffing is visible on the inner blister this is consistent with damage to the pack causing micromotion within the blister.Scratches were visible on the returned device however the device was returned loose in the unit carton and would be damaged during transportation.Clinician review: not performed as no medical records were received for review with a clinical consultant.Product history review: indicated all devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: (b)(4) unit carton with shrink wrap and an national loaner west label was returned for evaluation.The shrink wrap was opened on one end.Damage and multiple indentation lines are visible on the unit carton.The outer blister with the inner blister place inside it was inside the unit carton.The device (mrs head) was loose in the unit carton.The outer blister was returned with the tyvek lid remaining attached on one side to the blister.One side flange was cracked/broken away from the outer blister.The flange remains attached to the tyvek lid.There is evidence of a good seal on the three sides of the blister.Dark foreign matter/substance what appears to be blood is visible on the tyvek lid.The inner blister was returned inside the outer blister with the tyvek lid attached on one side.There is evidence of a good seal on the inner blister.Dark foreign matter/substance is visible on the tyvek lid of the inner blister.Scuffing is visible on the inner blister this is consistent with damage to the pack causing micromotion within the blister.Scratches were visible on the returned device however the device was returned loose in the unit carton and would be damaged during transportation.The investigation concluded that the packaging damage was most likely caused by excessive/incorrect handling prior to the opening packaging whereby the carton may have been compressed and/or dropped from a height causing the damage to the carton.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

• Brand Name: MRS 44MM PROXIMAL HUMERAL HEAD
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8703574
• Report Number: 0002249697-2019-02267
• Device Sequence Number: 2211390
• Product Code: HSD
• UDI-Device Identifier: 07613327048681
• UDI-Public: 07613327048681
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K954559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 64875044
• Device Lot Number: BT23P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR