MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI-HA 9X25 STERILE; SCREW, FIXATION, BONE

Model Number	7207681
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during acl reconstruction, when the screw box was opened, the screw was found broken.Backup device was available to complete the procedure.No delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection revealed that the packaging had been opened and the box had suffered some damage.The screw had multiple scratches and indentations, as well as a large crack from the proximal end to the middle.Most of the indentations were on the threads opposite the crack.There was gray discoloration or debris of unknown origin between the threads and throughout the inside of the screw.A review of the device 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 drawing found that parts must be free of visible voids, sinks, and weld lines.The complaint was confirmed, but the root cause could not be determined.Factors that could have contributed to the reported event include rough shipping and handling, an impact event during transportation or at the customer site, attempted reuse or repackaging of a device, or improper techniques for opening packaging.No containment or corrective actions are recommended at this time.

• Brand Name: SCR BIORCI-HA 9X25 STERILE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11239849
• Report Number: 1219602-2021-00214
• Device Sequence Number: 17030092
• Product Code: HWC
• UDI-Device Identifier: 03596010460004
• UDI-Public: 03596010460004
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K002274
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2021

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: 09/25/2024
• Device Model Number: 7207681
• Device Catalogue Number: 7207681
• Device Lot Number: 50830198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 03/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1