MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MRS HUMERAL STEM 9MM X 115MM; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Catalog Number	64873115
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.Review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.
Event or Problem Description
A company representative reported that during surgery it was discovered when the package of a stem was opened that the inner packaging was punctured by the stem.The device was not used.The surgeon had to switch to a different implant size.
Additional Manufacturer Narrative
An event regarding packaging damage involving a mrs stem was reported.The event was confirmed through visual inspection.Device evaluation and results: visual inspection was performed on the returned device which concluded: two outer blisters without their tyvek lid, the inner (blister) skin pack complete with the rigid lid of the skin pack, the stem and one end cap were returned for evaluation.No unit carton was returned.There is evidence of a full seal on the both returned outer blisters.The inner (blister) skin pack was returned with the tyvek lid still attached to the corner of the blister.The tyvek lid has what appears to be blood stains on it.The inner (blister) skin pack is deformed and there is extensive scuffing throughout there is also a small hole present in the corner of the blister.This damage is most likely from the relative movement of the stem component within the pack.One end cap was returned with the packaging.Medical records received and evaluation: not performed as there was no patient involvement.Device history review: dhr review for the reported lot determined that the device was manufactured and packed to specification.-complaint history review: review determined that there were no other similar reported events for the lot.Conclusions: based on the visual inspection damage is most likely caused by relative movement of the stem component within the inner blister.However as the unit carton itself has not been returned, the exact cause of the event could not be determined.No further investigation is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available this investigation will be reopened.
Event or Problem Description
A company representative reported that during surgery it was discovered when the package of a stem was opened that the inner packaging was punctured by the stem.The device was not used.The surgeon had to switch to a different implant size.

• Brand Name: MRS HUMERAL STEM 9MM X 115MM
• Common Device Name: PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6680903
• Report Number: 0002249697-2017-02095
• Device Sequence Number: 136940
• Product Code: HSD
• UDI-Device Identifier: 07613327049022
• UDI-Public: 07613327049022
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K954559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2017

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: 11/06/2020
• Device Catalogue Number: 64873115
• Device Lot Number: 155772B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2017
• Initial Date Received by Manufacturer: 06/06/2017
• Supplement Date Received by Manufacturer: 08/31/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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: 48 YR