MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH STERILE FLUTED HEADLESS 1/8" PIN 3.5" LONG; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	7650-2038A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the device history records indicate the devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.It was noted that the device is not available for evaluation.If additional information is received, it will be provided in the supplemental report upon completion of the investigation.
Event or Problem Description
Inner and outer packing had a hole through them, pins were discarded.

• Brand Name: STERILE FLUTED HEADLESS 1/8" PIN 3.5" LONG
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6826679
• Report Number: 0002249697-2017-02616
• Device Sequence Number: 10780278
• Product Code: LXH
• UDI-Device Identifier: 07613327255959
• UDI-Public: 07613327255959
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/29/2017

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: 06/08/2022
• Device Catalogue Number: 7650-2038A
• Device Lot Number: RDCK134L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 08/29/2017
• 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