MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INSERTER, BIOSURE SYNC; ACCESSORIES,ARTHROSCOPIC

Model Number	72202752
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the black plastic sleeve broke off during implant insertion.Correct surgical technique used.Proper sized dilator was used prior to sync implant insertion.Plastic chip was retrieved and discarded.No patient injury was reported.
Additional Manufacturer Narrative
A 72202752 biosure sync inserter instrument was reported on.Based upon the information provided, the failure was with the radel inserter guide sheath that cracked.The product was not returned for evaluation.Due to product unavailability, the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation were not fully possible without evaluation of physical product.If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint will certainly be revisited.Factors that may affect device performance include: device ability, surgical ability, implant location and tissue condition.Review of instruction for use (ifu) (b)(4) documentation confirms instructions, precautionary statements and recommendations for proper use of product.Influences that could compromise product performance or integrity that are unrelated to manufacture include: as a reusable device; prior damage or loss of integrity unrealized.Incompatible cleaning agents causing degradation to components.Conflicting force or torque applied.
Additional Manufacturer Narrative
One 72202752 biosure sync inserter instrument returned.The complaint indicated that the failure was with the radel inserter guide sheath that cracked.It was received with that component attached.There was a piece of the sleeve missing where it had cracked.It is at the spring-loaded locking pin should seat in a notch.As with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.Use of approved cleaning agents may affect plastic and delrin components.Low-sudsing, neutral 6.0¿8.0 ph, enzymatic detergents are recommended.Do not use detergents above 11.0 ph.Use deionized water for washing and rinsing.Inspect the device and any flexible portion for wear or cracking.Discard the device if any wear is observed or if the tip becomes dull.As with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.No root cause related to the manufacturing of this device was confirmed.

• Brand Name: INSERTER, BIOSURE SYNC
• Common Device Name: ACCESSORIES,ARTHROSCOPIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7952213
• Report Number: 1219602-2018-01390
• Device Sequence Number: 13688312
• Product Code: NBH
• UDI-Device Identifier: 03596010649010
• UDI-Public: (01)03596010649010(10)50644810
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/21/2018

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 Model Number: 72202752
• Device Catalogue Number: 72202752
• Device Lot Number: 50644810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Initial Date Received by Manufacturer: 09/17/2018
• Supplement Date Received by Manufacturer: 10/31/2018; 11/20/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 11/01/2018; 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR