MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PIN PASSING 2.4MM TROCAR 17; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 7207220

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 09/28/2022

Event Type  malfunction  

Event Description

It was reported that the sterile packaging of a pin passing was damaged.In the images provided, it was noticed that the sterile packaging was punctured, it had small holes in it.No case reported; therefore, no patient was involved.

Manufacturer Narrative

Internal complaint reference: (b)(4).

Manufacturer Narrative

H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation as it was discarded by healthcare facility staff, thus visual inspection and functional testing could not be performed.A review of the customer provided images found that the packaging of the device had several holes.The distal tip of the device appears to have punctured through the protective sleeve.There was a relationship found between the device and the reported event.The complaint was confirmed, and the root cause was associated with transport or storage of the device.Factors that could have contributed to the reported event include an application of unintended inappropriate or excessive force to the device or inappropriate storage conditions.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.A complaint history review found no similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the packaging instructions found that the tpu sleeves are inspected upon insertion into the pouch for damage or punctures.If the tpu sleeve is damaged or punctured, the damaged sleeve is removed and a new one is applied.The pouch is verified to be free of pin holes, cuts, and supplier seal defects.A review of the packaging design verification report found that all risks associated with packaging failures have been reduced to the lowest possible level and the packaging meets the requirements of eu mdr.A quality hold was issued to contain remaining units of this lot and no further actions are deemed necessary at this time.E1 data was corrected.

• Brand Name: PIN PASSING 2.4MM TROCAR 17
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15634146
• MDR Text Key: 302171937
• Report Number: 1219602-2022-01576
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 03596010375315
• UDI-Public: 03596010375315
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7207220
• Device Catalogue Number: 7207220
• Device Lot Number: 2083929
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1