MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH 6.5MM LOW PROFILE HEX SCREW 25MM; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Model Number	7030-6525
Medical Device Problem Codes	Material Discolored (1170); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was noted that the device is not available for evaluation.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.
Event or Problem Description
Primary tha.It was reported that after opening the outer sterile blister, the corner of the inner sterile packet was discolored.The device was refused before it entered the sterile field and another screw (different lot) was opened and used to complete the procedure successfully with no delay.
Event or Problem Description
Primary tha.It was reported that after opening the outer sterile blister, the corner of the inner sterile packet was discolored.The device was refused before it entered the sterile field and another screw (different lot) was opened and used to complete the procedure successfully with no delay.Rep retained all packaging, provided the usage sheet (which does not show the wasted screw), confirmed he was present for and witnessed the procedure, and confirmed that no further information will be released by the hospital or surgeon.
Additional Manufacturer Narrative
Reported event: an event regarding packaging issue involving a other hip screw was reported.The event was confirmed via product evaluation.Method & results: product evaluation and results: visual inspection of the returned device noted the following: device was returned new still inside the packaging.The outer blister is observed to be open and a corner of the inner sterile blister around the seal flange was discolored confirming the reported packaging issue event.Clinician review: no medical records were received for review with a clinical consultant.Product 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 lot referenced.Conclusions: visual inspection of the returned device noted the following: device was returned new still inside the packaging.The outer blister is observed to be open and a corner of the inner sterile blister around the seal flange was discolored confirming the reported packaging issue event.Nc was initiated to evaluate the root cause of the event.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: 6.5MM LOW PROFILE HEX SCREW 25MM
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 10861066
• Report Number: 0002249697-2020-02490
• Device Sequence Number: 2862703
• Product Code: LPH
• UDI-Device Identifier: 07613327345001
• UDI-Public: 07613327345001
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K161569
• 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): 01/19/2021

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: 07/31/2024
• Device Model Number: 7030-6525
• Device Catalogue Number: 7030-6525
• Device Lot Number: 4DYD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 01/19/2021
• 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: 60 YR