MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR BIORCI 8X30MM STRL BX 1; SCREW, FIXATION, BONE

Catalog Number	7207561
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acl reconstruction surgery, when the device was being implanted, the front end broke off.No patient injuries or significant delay reported.Back-up device was available.All the broken pieces were removed from the patient's anatomy.
Additional Manufacturer Narrative
One 8x30mm biorci screw was returned for evaluation.Visual assessment of the screw confirmed the reported complaint of breakage.Approximately 6.5mm off the distal threads have broken off and were not returned for examination.Dimensional assessment of the screws major diameter and wall thickness was performed and found to meet print specifications.An exact root cause cannot be determined with confidence with the limited clinical details provided; however, factors that could have contributed to the reported event include: not using a starter or tap prior to insertion of the screw.The instruction for use were reviewed and were found to outline precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SCR BIORCI 8X30MM STRL BX 1
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8932793
• Report Number: 1219602-2019-01021
• Device Sequence Number: 1948323
• Product Code: HWC
• UDI-Device Identifier: 03596010426239
• UDI-Public: 03596010426239
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K992396
• 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): 09/16/2019

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: 04/19/2021
• Device Catalogue Number: 7207561
• Device Lot Number: 50596915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 08/26/2019
• Supplement Report FDA Received Date: 09/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 75