MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE PK, 9 X 30MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72202273
Health Effect - Clinical Codes	Cyst(s) (1800); Pain (1994)
Date of Event	10/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that patient had an acl reconstruction.Patient came back complaining of pain around the tibial fixation site.Mri shows large cysts containing around 40-50ml of a jelly like substance.A second surgery was required years after the initial acl to remove the screws.
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that a patient had an acl reconstruction.Patient came back complaining of pain around the tibial fixation site.Mri shows large cysts containing around 40-50ml of a jelly like substance.A second surgery was required years after the initial acl to remove the screws.
Additional Manufacturer Narrative
Due no product return, the complaint could not be confirmed.Definitive conclusions cannot be made without a device to evaluate.Accurate investigation and evaluation are not possible.The product met specifications upon release to distribution.

• Brand Name: BIOSURE PK, 9 X 30MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7041554
• Report Number: 1219602-2017-01439
• Device Sequence Number: 16499781
• Product Code: MBI
• UDI-Device Identifier: 03596010622082
• UDI-Public: (01)03596010622082(17)200910(10)50565233
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K083635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/03/2018

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: 09/10/2020
• Device Model Number: 72202273
• Device Catalogue Number: 72202273
• Device Lot Number: 50565233
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2017
• Supplement Date Received by Manufacturer: 11/16/2017; 11/16/2017; 01/02/2018
• Initial Report FDA Received Date: 11/17/2017
• Supplement Report FDA Received Date: 11/17/2017; 11/17/2017; 01/03/2018
• 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: 39 YR