MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACROMIOBLASTER 4.0MM EP-1 DSPL BLADE; SAW, POWERED, AND ACCESSORIES

Model Number	7205668
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	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).
Event or Problem Description
It was reported that the acromioblaster 4.0mm ep-1 dspl blade was found to have a hair inside the main packaging.It is unknown whether the event happened during surgery and if there was a patient involvement all available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h2, h6.The reported device, intended for use in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.There was a relationship found between the returned device and the reported incident.An analysis of the customer provided images revealed a dark fiber or marking present in clear plastic packaging.The device had been removed from the packaging, indicating that the package had been opened.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of the final assembly visual inspection procedure found that particulates/foreign material within the seal or within the package were specified appropriately.The complaint was confirmed, but the root cause could not be established without evaluation.Factors that may have contributed include a breach in the device seal, environmental contamination, or inadvertent contamination during opening.

• Brand Name: ACROMIOBLASTER 4.0MM EP-1 DSPL BLADE
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11120904
• Report Number: 1219602-2021-00046
• Device Sequence Number: 17046307
• Product Code: HAB
• UDI-Device Identifier: 03596010293084
• UDI-Public: 03596010293084
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2021

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: 03/02/2023
• Device Model Number: 7205668
• Device Catalogue Number: 7205668
• Device Lot Number: 50718350
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 02/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1