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

Model Number 704011S

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2021

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

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 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
• Type of Device: 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
• MDR Text Key: 284899780
• Report Number: 0008031020-2021-00507
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 04546540113085
• UDI-Public: 04546540113085
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1