MAUDE Adverse Event Report: STRYKER GMBH GUIDE PIN COCR, THREADED TIP OMEGA 3 Ø2.8MMX230MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	704011S
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the nurse open the sterile pack, they found the insect in the sterile pack.They replaced to the new one and continued the procedure.
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since fragments of an insect were returned together with the device.The device inspection revealed the following: the device was returned in the original package.The reported catalog- and lot number can be confirmed based on the original label on the left side.Next to this label is a local label and a local leaflet in a plastic insert visible on the package.Both are additions that were not applied during the manufacturing process and the original shrinking foil was removed to add these additions.The guide pin is still in the sterile blister, on the right side of the blister is a adhesive tape visible.This adhesive tape was applied to show the insect that was in the package.It can be confirmed that there are pieces of an insect attached to this tape, but is not possible to identify what kind of insect it was as only small fragments of it were returned.The blister with the sterile guide pin is not affected by the issue.The foil is still properly attached and there are no fragments of the insect visible in the blister.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.The review of the manufacturing process has shown that there are several measurements in place to avoid such an occurrence.The process requires that the boxes are knocked out before the blister is inserted, thereby insects would fall out.There are at different places insect annihilators and insect traps installed at the for the packaging relevant places.These devices are regularly checked and during the checks in the period where the device was manufactured no insects could be detected.These findings speak against a manufacturing related issue.The root cause can afterwards not be defined as it is not possible to say if the insect found a way into the package during transportation, storage or handling after the package did leave the manufacturing site.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that when the nurse open the sterile pack, they found the insect in the sterile pack.They replaced to the new one and continued the procedure.

• Brand Name: GUIDE PIN COCR, THREADED TIP OMEGA 3 Ø2.8MMX230MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 13102199
• Report Number: 0008031020-2021-00507
• Device Sequence Number: 3693831
• Product Code: LXH
• UDI-Device Identifier: 04546540113085
• UDI-Public: 04546540113085
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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 Expiration Date: 06/30/2026
• Device Model Number: 704011S
• Device Catalogue Number: 704011S
• Device Lot Number: 23126H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2021
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2021
• 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