MAUDE Adverse Event Report: STRYKER GMBH SELF-DRILLING HALF PIN APEX Ø 5MM, 150 X 40MM; PIN, FIXATION, THREADED

Model Number	5018-5-150
Medical Device Problem Code	Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown, it was not shipped to the hospital.
Event or Problem Description
As reported: "in a case where the apexpin sharp end should have been shipped, the blunt end was shipped in error.Finally, another company's product was used, but there was a 30-minute delay.".
Event or Problem Description
As reported: "in a case where the apexpin sharp end should have been shipped, the blunt end was shipped in error.Finally, another company's product was used, but there was a 30-minute delay.".
Additional Manufacturer Narrative
***correction - please refer to h6 results & conclusion codes.The reported event wrong part delivered to customer (surgeon ordered a sharp end apex pin by sales rep.But the sales rep.Ordered a blunt end apex pin for the surgeon by distribution) could be confirmed, since distribution confirmed the issue and launched a nc for further investigation of the event.

• Brand Name: SELF-DRILLING HALF PIN APEX Ø 5MM, 150 X 40MM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13171448
• Report Number: 0008031020-2022-00007
• Device Sequence Number: 4780631
• Product Code: JDW
• UDI-Device Identifier: 07613327091939
• UDI-Public: 07613327091939
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2022

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 Model Number: 5018-5-150
• Device Catalogue Number: 50185150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2021
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown