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

Model Number	7205326
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported lost of metal blade fragments in the patient while scraping the bone.It is unknown if all the fragments were removed from the patient.No significant procedure delay was reported.Back up device was available.
Additional Manufacturer Narrative
Due to no product return the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.No further actions pursued at this time.If objective evidence, relevant information or product becomes available to assist with evaluation, the complaint will certainly be revisited.

• Brand Name: ACROMIONIZER,4.0 EP-1,DSPL BL
• Common Device Name: SAW, POWERED, AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7681989
• Report Number: 1219602-2018-00894
• Device Sequence Number: 10933684
• Product Code: HAB
• UDI-Device Identifier: 03596010251541
• UDI-Public: (01)03596010251541(17)230215(10)50715057
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2023
• Device Model Number: 7205326
• Device Catalogue Number: 7205326
• Device Lot Number: 50715057
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR